Systems and methods for post-operative outcome monitoring

ABSTRACT

A system including a range of motion module, a quality of sleep module, an overall module, and a control module. The range of motion module, subsequent to performing a procedure on a patient, determines a first range of motion score of the patient based on a signal generated by a sensor. The quality of sleep module, subsequent to performing the procedure on the patient, determines a first quality of sleep score or a first pain score based on the signal generated by the sensor. The overall module determines a combined score based on (i) the first range of motion score, and (ii) the first sleep score or the first pain score. The control module (i) determines whether an outcome of the procedure is positive based on the combined score, and (ii) stores the determined outcome and the combined score in a memory.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit to U.S. application Ser. No. 14/945,167,filed on Nov. 18, 2015, and entitled “SYSTEMS AND METHODS FORPOST-OPERATIVE MONITORING”. Moreover, the present disclosure relates toU.S. application Ser. No. 14/945,208, filed on Nov. 18, 2015, andentitled “SYSTEMS AND METHODS FOR PRE-OPERATIVE PROCEDURE DETERMINATIONAND OUTCOME PREDICTING”, now U.S. Pat. No. 10,339,273. The disclosuresof the above applications are incorporated herein by reference in theirentirety.

FIELD

The present disclosure relates to patient sensor monitoring systems anddevices.

BACKGROUND

The background description provided herein is for the purpose ofgenerally presenting the context of the disclosure. Work of thepresently named inventors, to the extent the work is described in thisbackground section, as well as aspects of the description that may nototherwise qualify as prior art at the time of filing, are neitherexpressly nor impliedly admitted as prior art against the presentdisclosure.

A subject, such as a human patient, may select or be required to undergoa surgical procedure to correct or augment an anatomy of the patient.The augmentation of the anatomy can include various procedures, such asmovement or augmentation of bone, insertion of implantable devices, orother appropriate procedures. A surgeon can perform the procedure on thepatient based on images of the patient, which can be acquired using anx-ray scanner having an imaging system. The images may be acquired priorto or during the procedure. The imaging system may be, for example, anO-Arm® or C-arm imaging system or a kinematics imaging system. Theimages may be fluoroscopic or radiographic images depending on anoperating mode of the imaging system.

The acquired images of the patient can assist a surgeon in planning andperforming the procedure. A surgeon may select a two dimensional imageor a three dimensional image representation of the patient. The imagescan assist the surgeon in performing a procedure with a less invasivetechnique by allowing the surgeon to view the anatomy of the patientwithout removing overlying tissue (including dermal and muscular tissue)when performing a procedure.

An O-Arm imaging system includes an ‘O’-shaped gantry and a ‘O’-shapedrotor. A C-Arm imaging system includes a ‘C’-shaped gantry and a‘C’-shaped rotor. Each of these imaging systems typically includes anx-ray source and an x-ray detector mounted opposite each other on thecorresponding rotor. Each of the x-ray sources generates x-rays, whichare directed at a subject. Each of the x-ray detectors detects thex-rays subsequent to the x-rays passing through the subject.

Prior to performing a procedure, a surgeon must determine whether aprocedure is needed and estimate a probability that the procedure willbe successful. Currently, spinal surgeons generally determine the needfor surgery in a subjective manner after a physical examination and areview of x-ray images of a patient. Arbitrary “cut-points” can bedetermined based on surgical experience of the surgeon.

SUMMARY

A system is provided and includes a range of motion module, a quality ofsleep module, an overall module, and a control module. The range ofmotion module is configured to, subsequent to performing a procedure ona patient, determine a first range of motion score of the patient basedon a signal generated by a sensor. The quality of sleep module isconfigured to, subsequent to performing the procedure on the patient,determine a first quality of sleep score or a first pain score based onthe signal generated by the sensor. The overall module is configured todetermine a combined score based on (i) the first range of motion score,and (ii) the first sleep score or the first pain score. The controlmodule is configured to (i) determine whether an outcome of theprocedure is positive based on the combined score, and (ii) store thedetermined outcome and the combined score in a memory.

In other features, a method is provided and includes: subsequent toperforming a procedure on a patient, determining a first range of motionscore of the patient based on a signal generated by a sensor; subsequentto performing the procedure on the patient, determining a first qualityof sleep score or a first pain score based on the signal generated bythe sensor; determining a combined score based on (i) the first range ofmotion score, and (ii) the first sleep score or the first pain score;determining whether an outcome of the procedure is positive based on thecombined score; and storing the determined outcome and the combinedscore in a memory.

Further areas of applicability of the present disclosure will becomeapparent from the detailed description, the claims and the drawings. Thedetailed description and specific examples are intended for purposes ofillustration only and are not intended to limit the scope of thedisclosure.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 is an environmental view of an imaging system in an operatingtheatre, including gantry positioning system in accordance with anembodiment of the present disclosure.

FIG. 2A is an environmental view of a spinal kinematics system includinga positioning system in accordance with an embodiment of the presentdisclosure.

FIG. 2B is a perspective view of the positioning system of FIG. 2Aillustrating x-ray imaging.

FIG. 3 is a perspective view of a wireless monitoring systemincorporating sensors in accordance with the present disclosure.

FIG. 4 is a functional block diagram of a sensing module, a consoleinterface module and a monitoring device in accordance with the presentdisclosure.

FIG. 5 is a functional block diagram of another sensing module andanother monitoring device in accordance with the present disclosure.

FIG. 6 is a functional block diagram of another sensing module inaccordance with the present disclosure.

FIG. 7 is a signal flow diagram illustrating a sensor joining andcommunicating in a wireless monitoring system in accordance with thepresent disclosure.

FIG. 8 is a view of a functional block diagram of a portion of a controlmodule in accordance with an embodiment of the present disclosure.

FIG. 9 illustrates a pre-operation (Pre-Op) method in accordance withthe present disclosure.

FIG. 10 illustrates a post-operation (Post-Op) method in accordance withthe present disclosure.

FIG. 11 is a table of pre-operation and post-operation range of motionand pain scores in accordance with the present disclosure.

In the drawings, reference numbers may be reused to identify similarand/or identical elements.

DESCRIPTION

The following disclosed examples include pre-operative andpost-operative monitoring of relevant physiologic parameters. Theparameters are analyzed to determine “cut-points” and whetherperformance of a procedure is likely to provide a positive outcome. Thisprovides a surgeon with an objective method to determine whether aspinal procedure is likely to provide a positive outcome.

A current standard of care for spinal fusion and other spinal surgicalprocedures does not include pre-operative variable data techniques todetermine both (i) whether a procedure should be performed, and (ii) ifthe procedure is performed, whether the procedure has an acceptableprobability to achieve a positive outcome. The following disclosedexamples provide objective thresholds (or objective “cut-points”) fordetermining whether to perform a procedure based on a probability of apositive outcome. The examples include pre-operative and post-operativemonitoring of various parameters and may include determiningsensor-based and/or image-based “cut-points” for determining a need forsurgery. The following examples include pre-operative data collectionand monitoring of physiological parameters, which may be combined withpre-operative imaging techniques, to achieve predictive positiveoutcomes.

FIG. 1 shows an operating theatre (or inside of an operating room) 10and a user 12 (e.g., a physician) performing a procedure on a subject(e.g., a patient) 14. In performing the procedure, the user 12 uses aprocedural operating system 13 that includes an imaging system 16 toacquire image data of the patient 14. The image data acquired of thepatient 14 can include two-dimension (2D) or three-dimensional (3D)images. Models may be generated using the acquired image data. The modelcan be a three-dimension (3D) volumetric model generated based on theacquired image data using various techniques, including algebraiciterative techniques. The image data (designated 18) can be displayed ona display device 20, and additionally, may be displayed on a displaydevice 32 a associated with an imaging computing system 32. Thedisplayed image data 18 may include 2D images, 3D images, and/or a timechanging 4D images. The displayed image data 18 may also includeacquired image data, generated image data, and/or a combination of theacquired and generated image data.

Image data acquired of a patient 14 may be acquired as 2D projections.The 2D projections may then be used to reconstruct 3D volumetric imagedata of the patient 14. Also, theoretical or forward 2D projections maybe generated from the 3D volumetric image data. Accordingly, image datamay be used to provide 2D projections and/or 3D volumetric models.

The display device 20 may be part of a computing system 22. Thecomputing system 22 may include a variety of computer-readable media.The computer-readable media may be any available media that is accessedby the computing system 22 and may include both volatile andnon-volatile media, and removable and non-removable media. By way ofexample, the computer-readable media may include computer storage mediaand communication media. Storage media includes, but is not limited to,RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM,Digital Versatile Disk (DVD) or other optical disk storage, magneticcassettes, magnetic tape, magnetic disk storage or other magneticstorage devices, or any other medium which can be used to storecomputer-readable instructions, software, data structures, programmodules, and other data and which can be accessed by the computingsystem 22. The computer-readable media may be accessed directly orthrough a network such as the Internet.

In one example, the computing system 22 can include an input device 24,such as a keyboard, and one or more processors 26 (the one or moreprocessors may include multiple-processing core processors,microprocessors, etc.) that may be incorporated with the computingsystem 22. The input device 24 may include any suitable device to enablea user to interface with the computing system 22, such as a touchpad,touch pen, touch screen, keyboard, mouse, joystick (sometimes referredto as a joystick controller), trackball, wireless mouse, audible controlor a combination thereof. Furthermore, while the computing system 22 isdescribed and illustrated herein as comprising the input device 24discrete from the display device 20, the computing system 22 may includea touchpad or tablet computing device and may be integrated within or bepart of the imaging computing system 32. A connection (or communicationline) 28 may be provided between the computing system 22 and the displaydevice 20 for data communication to allow driving the display device 20to illustrate the image data 18.

The imaging system 16 may be an O-Arm® imaging system, a C-Arm imagingsystem or other suitable imaging system. The imaging system 16 mayinclude a mobile cart 30, the imaging computing system 32 and a gantry34 (or x-ray scanner gantry). The gantry 34 includes an x-ray source 36,a collimator (not shown), a multi-row detector 38, a flat panel detector40 and a rotor 42. The mobile cart 30 may be moved from one operatingtheater or room to another and the gantry 34 may be moved relative tothe mobile cart 30. This allows the imaging system 16 to be mobile andused for various procedures without requiring a capital expenditure orspace dedicated to a fixed imaging system. Although the gantry 34 isshown as being mobile, the gantry 34 may not be connected to the mobilecart 30.

The imaging system 16, the mobile cart 30 and/or the imaging computingsystem 32 may include motors, positioning devices, coupling members,circuit elements, controllers (or control modules), sensors, etc.(examples of which are shown in and described with respect to FIGS. 3-6)for moving and orienting the gantry 34 relative to the table 15 and/orthe patient 14. The motors, positioning devices, coupling members,circuit elements, controllers (or control modules), sensors, etc. arepart of a gantry positioning system 35.

The gantry 34 may define an isocenter of the imaging system 16. In thisregard, a centerline C1 through the gantry 34 defines an isocenter orcenter of the imaging system 16. Generally, the patient 14 can bepositioned along the centerline C1 of the gantry 34, such that alongitudinal axis of the patient 14 is aligned with the isocenter of theimaging system 16.

The imaging computing system 32 may control the movement, positioningand adjustment of the multi-row detector 38, the flat panel detector 40and the rotor 42 independently to enable image data acquisition via animage processing module 43 of the processor 26. The processed images maybe displayed on the display device 20.

During operation, the source 36 emits x-rays through the patient 14,which are detected by the multi-row detector 38 or the flat paneldetector 40. The x-rays emitted by the source 36 may be shaped by thecollimator and emitted for detection by the multi-row detector 38 or theflat panel detector 40. The collimator may include one or more leaves,which may be controlled to shape the x-rays emitted by the source 36.The collimator may shape the x-rays emitted by the source 36 into a beamthat corresponds with the shape of the multi-row detector 38 and theflat panel detector 40. The multi-row detector 38 may be selected toacquire image data of low contrast regions of the anatomy, such asregions of soft tissue. The flat panel detector 40 may be selected toacquire image data of high contrast regions of the anatomy, such asbone. The source 36, the collimator, the multi-row detector 38 and theflat panel detector 40 may each be coupled to and/or mounted on therotor 42.

The multi-row detector 38 and the flat panel detector 40 may be coupledto the rotor 42 to be (i) diametrically opposed from the source 36 andthe collimator within the gantry 34, and (ii) independently movablerelative to each other and into alignment with the source 36 and thecollimator. In one example, the multi-row detector 38 may be positionedsuch that the flat panel detector 40 may be adjacent to the multi-rowdetector 38. In one alternative example, the flat panel detector 40 maybe moved over the multi-row detector 38 into alignment with the source36 when an image using the flat panel detector 40 is acquired. Inanother example, the multi-row detector 38 may be positioned over theflat panel detector 40. As a further alternative, the multi-row detector38 and the flat panel detector 40 may each be separately movable, suchthat the selected multi-row detector 38 or flat panel detector 40 may bealigned with the source 36 and the collimator. The selected one of themulti-row detector 38 and the flat panel detector 40 may be aligned withthe source 36 and the collimator when the selected one of the multi-rowdetector 38 and the flat panel detector 40 is substantially opposite orabout 180 degrees apart from the source 36 and the collimator.

As the source 36, collimator, multi-row detector 38 and flat paneldetector 40 are coupled to the rotor 42, the source 36, collimator,multi-row detector 38 and flat panel detector 40 are movable within thegantry 34 about the patient 14. Thus, the multi-row detector 38 and theflat panel detector 40 are able to be rotated in a 360° motion aroundthe patient 14, as indicated by arrow 39. The source 36 and collimatormay move in concert with at least one of the multi-row detector 38 andthe flat panel detector 40 such that the source 36 and collimator remaingenerally 180° apart from and opposed to the multi-row detector 38 orflat panel detector 40.

The gantry 34 has multiple degrees of freedom of motion. The gantry 34may be isometrically swayed or swung (herein also referred to asiso-sway) relative to table 15 on which the patient 14 is disposed. Theisometric swing (sometimes referred to as a wag (or yaw) angle or wagaxis) is indicated by arrow 41. The gantry 34 may be: tilted relative tothe patient 14 as indicated by arrow 45 (sometimes referred to as thetilt (or roll) angle or tilt axis); moved longitudinally relative to thepatient 14 as indicated by arrow 44 (sometimes referred to as thez-axis); moved up and down relative to the mobile cart 30 andtransversely to the patient 14 as indicated by arrow 46 (sometimesreferred to as the y-axis); moved away from or towards the mobile cart30 as indicated by arrow 48 (sometimes referred to as the x-axis); androtated about a point on the mobile cart 30 as indicated by arrow 49(sometimes referred to as a pitch angle or pitch axis). The degrees offreedom of motion may be represented using the Cartesian coordinatesystem. These degrees of freedom of motion are provided by the gantrypositioning system 35 and allow a user to move the gantry relative tothe table 15 and the patient 14 with minimal effort by the user. Thesedifferent degrees of freedom of motion of the gantry 34 allow the source36, collimator, multi-row detector 38 and flat panel detector 40 to bepositioned relative to the patient 14.

The imaging system 16 may be precisely controlled by the imagingcomputing system 32 to move the source 36, collimator, the multi-rowdetector 38 and the flat panel detector 40 relative to the patient 14 togenerate precise image data of the patient 14. In addition, the imagingsystem 16 may be connected with the processor 26 via connection 50 whichincludes a wired or wireless connection or physical media transfer fromthe imaging system 16 to the processor 26. Thus, image data collectedwith the imaging system 16 may also be transferred from the imagingcomputing system 32 to the computing system 22 for navigation, display,reconstruction, etc.

The imaging system 16 may also be used during an unnavigated ornavigated procedure. In a navigated procedure, a localizer, includingeither or both of an optical localizer 60 and an electromagneticlocalizer 62, may be used to generate a field or receive or send asignal within a navigation domain relative to the patient 14. Ifdesired, the components of a navigation system associated withperforming a navigated procedure may be integrated within the imagingsystem 16. The navigated space or navigational domain relative to thepatient 14 may be registered to the image data 18 to allow registrationof a navigation space defined within the navigational domain and animage space defined by the image data 18. A patient tracker (or adynamic reference frame) 64 may be connected to the patient 14 to allowfor a dynamic registration and maintenance of the registration of thepatient 14 to the image data 18.

An instrument 66 may then be tracked relative to the patient 14 to allowfor a navigated procedure. The instrument 66 may include an opticaltracking device 68 and/or an electromagnetic tracking device 70 to allowfor tracking of the instrument 66 with either or both of the opticallocalizer 60 or the electromagnetic localizer 62. The instrument 66 mayinclude a communication line 72 with a navigation interface device 74,which may communicate with the electromagnetic localizer 62 and/or theoptical localizer 60. The navigation interface device 74 may thencommunicate with the processor 26 via a communication line 80. Theconnections or communication lines 28, 50, 76, 78, or 80 can be wirebased as shown or the corresponding devices may communicate wirelesslywith each other. The imaging system 16 having the integrated navigationsystem tracks the instrument 66 relative to the patient 14 to allow forillustration of the tracked location of the instrument 66 relative tothe image data 18 for performing a procedure.

The instrument 66 may be an interventional instrument and/or an implant.Implants may include a ventricular or vascular stent, a spinal implant,neurological stent or the like. The instrument 66 may be aninterventional instrument such as a deep brain or neurologicalstimulator, an ablation device, or other appropriate instrument.Tracking the instrument 66 allows for viewing the location of theinstrument 66 relative to the patient 14 with use of the registeredimage data 18 and without direct viewing of the instrument 66 within thepatient 14. For example, the instrument 66 may be graphicallyillustrated as an icon superimposed on the image data 18.

Further, the imaging system 16 may include a tracking device, such as anoptical tracking device 82 or an electromagnetic tracking device 84 tobe tracked with a respective optical localizer 60 or the electromagneticlocalizer 62. The tracking devices 82, 84 may be associated directlywith the source 36, multi-row detector 38, flat panel detector 40, rotor42, the gantry 34, or other appropriate part of the imaging system 16 todetermine the location or position of the source 36, multi-row detector38, flat panel detector 40, rotor 42 and/or gantry 34 relative to aselected reference frame. As illustrated, the tracking devices 82, 84may be positioned on the exterior of the housing of the gantry 34.Accordingly, portions of the imaging system 16 including the instrument66 may be tracked relative to the patient 14 to allow for initialregistration, automatic registration or continued registration of thepatient 14 relative to the image data 18.

The image processing module 43 may receive user input data from theinput device 32 c and may output the image data 18 to the display device20 or the display device 32 a. The user input data may include a requestto acquire image data of the patient 14. Based on the user input data,the image processing module 43 may generate a detector signal and amotion signal. The detector signal may include a selected detector forimage acquisition. The motion signal may include a motion profile forthe rotor 42 to move to a selected location to acquire image data. Themotion signal may be a command or instruction signal that is providedfrom the image processing module to a gantry control module 85. Thegantry control module 85 may be included in the imaging computing system32, on the mobile cart 30, or as part of the processor 26. The imageprocessing module 43 may also send a source signal to the source 36. Thesource signal may command the source 36 to output or emit at least oneor more x-ray pulses. The image processing module 43 may also send acollimator signal to the collimator. The collimator signal may indicatea selected shape of one or more collimated x-ray pulses. The selectedshape of the collimated x-ray pulses may correspond to the selected oneof the multi-row detector 38 and the flat panel detector 40. In thisregard, if the multi-row detector 38 is selected, the collimated x-raypulses may be shaped by the collimator to match the shape of themulti-row detector 38. If the flat panel detector 40 is selected, thenthe collimated x-ray pulses may be shaped by the collimator to match theshape of the flat panel detector 40.

The image processing module 43 may also receive as input a multi-rowdetector signal, which may include the one or more collimated x-raypulses detected by the multi-row detector 38. The image processingmodule 43 may receive as input a flat panel detector signal, which mayinclude the one or more collimated x-ray pulses detected by the flatpanel detector 40. Based on the received collimated x-ray pulses, theimage processing module 43 may generate the image data 18.

In one example, the image data 18 may include a single 2D image. Inanother example, the image processing module 43 may perform automaticreconstruction of an initial 3D model of an area of interest of thepatient 14. Reconstruction of the 3D model may be performed in anyappropriate manner, such as using algebraic techniques for optimization.The algebraic techniques may include Expectation maximization (EM),Ordered Subsets EM (OS-EM), Simultaneous Algebraic ReconstructionTechnique (SART) and total variation minimization. A 3D volumetricreconstruction may be provided based on the 2D projections.

The algebraic techniques may include an iterative process to perform areconstruction of the patient 14 for display as the image data 18. Forexample, a pure or theoretical image data projection, based on orgenerated from an atlas or stylized model of a “theoretical” patient,may be iteratively changed until the theoretical projection images matchthe acquired 2D projection image data of the patient 14. Then, thestylized model may be appropriately altered as the 3D volumetricreconstruction model of the acquired 2D projection image data of thepatient 14 and may be used in a surgical intervention, such asnavigation, diagnosis, or planning interventions. In this regard, thestylized model may provide additional detail regarding the anatomy ofthe patient 14, which may enable the user 12 to plan the surgicalintervention efficiently. The theoretical model may be associated withtheoretical image data to construct the theoretical model. In this way,the model or the image data 18 may be built based upon image dataacquired of the patient 14 with the imaging system 16. The imageprocessing module 43 may output the image data 18 to the display device32 a.

The gantry control module 85 may receive as an input the detector signaland the motion signal from the image processing module 43. The gantrycontrol module 85, based on the detector signal and the motion signalmay transmit (via wires or wirelessly) control signals to a rotorcontrol module 90. The rotor control module 90 may be located on therotor 42. Based on the detector signal, the gantry control module 85 maygenerate a first move signal to move the selected one of the multi-rowdetector 38 or the flat panel detector 40 into alignment with the source36 and the collimator. Based on the motion signal, the gantry controlmodule 85 may also generate a second move signal for the rotor 42 tomove or rotate the rotor 42 within the gantry 34 relative to the patient14. A third move signal may be generated based on the motion signal andprovided to the rotor control module 90. The rotor 42 may be rotated tomove the source 36, the collimator, the multi-row detector 38 and theflat panel detector 40 360° around the longitudinal axis of the patient14 within the gantry 34. The rotor may be continuously rotated in asingle direction more than 360°. The movement of the source 36, thecollimator, the multi-row detector 38 and the flat panel detector 40about the patient 14 may be controlled to acquire image data at selectedlocations and orientations relative to the patient 14.

The 2D image data may be acquired at each of multiple annular positionsof the rotor 42. The 3D image data may be generated based on the 2Dimage data. Also, the gantry 34, the source 36, the multi-row detector38 and the flat panel detector 40 may not be moved in a circle, butrather may be moved in another pattern, such as a spiral helix, or otherrotary movement about or relative to the patient 14. This can reduceexposure of a patient to radiation. The pattern (or path) may benon-symmetrical and/or non-linear based on movements of the imagingsystem 16, such as the gantry 34. In other words, the path may not becontinuous in that the gantry 34 may be stopped and moved back in adirection along the path the gantry 34 previously followed. This mayinclude following previous oscillations of the gantry 34.

The sensors, modules, processors and/or controllers of the systems 16,22, 32 may communicate with each other and share data, signals and/orinformation disclosed herein. Inputs to the imaging system 16 may bereceived at the input device 32 c, input device 24, or other controlmodules (not shown) within the computing system 22 or imaging computingsystem 32, and/or determined by other sub-modules (not shown) within theimage processing module 43. The image processing module 43 may receiveuser input data requesting that image data of the patient 14 beacquired. The input data may include information as to whether theregion of interest on the patient 14 is a high contrast region (e.g.boney tissue) or a low contrast region (e.g. soft tissue). In oneexample, the user input data may include a region of interest on theanatomy of the patient 14. The image processing module 43 mayautomatically determine to use the multi-row detector 38 or the flatpanel detector 40 based on the region of interest. For example, the usermay select (i) the multi-row detector 38 to acquire an image of softtissue, and (ii) the flat panel detector 40 to acquire an image of boneytissue.

Based on the user input data, the image processing module 43 maygenerate source data and detector type data. The image processing module43 may also generate motion profile data and collimator data. The sourcedata may include information to output x-ray pulses or a signal topower-down the imaging system 16. The detector type data may include theselected multi-row detector 38 or flat panel detector 40 to acquire theimage data. The motion profile data may include a selected profile forthe movement of the rotor 42 within the gantry 34. The collimator datamay include information to shape the x-ray pulses into collimated x-raypulses to match the selected one of the multi-row detector 38 and flatpanel detector 40.

The image processing module 43 may also receive as an input multi-rowdetector data and flat panel detector data. The multi-row detector datamay indicate the energy from the collimated x-ray pulses received by themulti-row detector 38. The flat panel detector data may indicate theenergy from the collimated x-ray pulses received by the flat paneldetector 40. Based on the multi-row detector data and the flat paneldetector data, the image processing module 43 may generate the imagedata 18 and may output this image data 18 to the display device 32 a ordisplay device 20.

The gantry control module 85 may receive as input the detector type dataand the motion profile data. Based on the detector type data, the gantrycontrol module 85 may generate flat panel move data or multi-row movedata (and/or corresponding signals). The flat panel move data mayinclude a selected position for the flat panel detector 40 to move to inorder to be aligned with the source 36 and collimator. The multi-rowmove data may include a selected position for the multi-row detector 38to move in order to be aligned with the source 36 and collimator.

The processor 26 or a module thereof, based on the source data, maycause the source 36 to generate pulse data for control of thecollimator. The pulse data may include pulse data for at least one x-raypulse. The processor 26 and/or a module thereof may receive as an inputthe multi-row move data and the collimated pulse data. Based on themulti-row move data, the multi-row detector 38 may move into alignmentwith the source 36. Based on the received pulse data, the processor 26and/or a module thereof may generate the multi-row detector data (and/ora corresponding signal) for the image processing module 43. Theprocessor 26 and/or a module thereof may receive as an input the flatpanel move data and the collimated pulse data. Based on the flat panelmove data, the flat panel detector 40 may move into alignment with thesource 36. Based on the received pulse data, the flat panel controlmodule may generate the flat panel detector data (and/or a correspondingsignal) for the image processing module 43.

Based on the motion profile data, the gantry control module 85 maygenerate rotor move data (and/or a corresponding signal) for the rotorcontrol module 90. The rotor move data may indicate a selected movementprofile for the rotor 42 to move within the gantry 34 to enable theacquisition of the image data. The rotor control module 90 may receiveas an input the rotor move data. Based on the rotor move data, the rotor42 may be moved within the gantry 34 to a desired location in order toacquire the image data.

FIGS. 2A and 2B show a spinal kinematics system 100 that performsvertebral motion analysis. The spinal kinematics system 100 includes apositioning system 102, an x-ray system 104, a kinematics control module(KCM) 106, and an image processing module (IPM) 108. Unlike traditionalx-rays taken to show bending of a spine in which a patient is free tobend as much as the patient desires, the positioning system 102 assiststhe patient through a complete spine bend. This helps to gently overcome“guarding” that often occurs during painful spine bending, which helpsto assure instability (or vertebra slippage) does not go undetected.

The positioning system 102 may include sensors 110 for detecting angularpositions of a patient and/or positions of vertebrae of the patient, asa patient bends his/her spine in forward and rearward directions. Thex-rays system 104 takes x-ray images during bending motion of thepatient to capture images of the spine of the patient. The KCM 106 mayreceive signals from the sensors 110, control the x-ray imaging system104, and provide the detected signals, related position information,and/or x-ray images to the IPM 108.

FIG. 3 shows a wireless monitoring system 150. The wireless monitoringsystem 150, as shown, includes sensors 152, a wireless interface adaptor(WIA) 156 and a monitoring device 158. The monitoring device 158 mayinclude an IPM 160. The IPM 160 may be implemented as and/or be incommunication with one or more of the IPMs 43, 108 of FIGS. 1-2. Themonitoring device 158 may be included in the systems of FIGS. 1-2. TheIPM 160 may include or be in communication with a procedure module 162,which may: perform pre-operative and post-operative monitoring ofparameters of a current patient and other patients; based on theparameters and previously stored outcomes of a procedure on the otherpatients, objectively determine whether the procedure should beperformed and/or needs to be performed on the current patient; based onthe parameters and corresponding outcomes of the procedure as previouslyperformed, determine “cut-points” (or thresholds) for determiningwhether to perform the procedure; and based on the parameters and thedetermined “cut-points”, predict an outcome of the procedure.

The WIA 156 includes a console interface module (CIM), which is shown inFIG. 4, and an interface 163 (e.g., a 32-pin connector) for connectingto the monitoring device 158. The WIA 156 is shown as being plugged intoa back side of the monitoring device 158. Although the WIA 156 is shownas being plugged into the monitoring device 158 via the interface 163,the WIA 156 may be separate from the monitoring device 158 andwirelessly communicate with the monitoring device 158. The sensors 152wirelessly communicate with the CIM and/or the monitoring device 158. Inone embodiment, the WIA 156 is connected to the monitoring device 158and wirelessly communicates with the sensors 152. In an alternativeembodiment, the monitoring device 158 includes the CIM and/or is indirect wireless communication with the sensors 152. Informationdescribed below as being transmitted from the monitoring device 158 tothe CIM may then be relayed from the CIM to the sensors 152. Informationand/or data described below as being transmitted from the sensors 152 tothe CIM may then be relayed from the CIM to the monitoring device 158.

The WIA 156: transfers signals between (i) the monitoring device 158 and(ii) the sensors 152; and/or adds additional information to the signalsreceived from the monitoring device 158 prior to forwarding the signalsto the sensors 152, as described below. The WIA 156 may: operateessentially as a pass through device; be a smart device and add and/orreplace information provided in received signals; and/or generatesignals including determined information based on received signals. Forexample, the WIA 156 may receive a payload request signal from themonitoring device 158 and determine a delay time between when thepayload request was received and when a next synchronization (SYNC)request signal is to be transmitted. The WIA 156 allows the monitoringdevice 158 to be compatible with legacy hardware. The WIA 156 may beunplugged from the monitoring device 158 and a traditional electrodeconnection box may be connected to the WIA 156 using the same interfaceof the monitoring device 158 as the WIA 156. The WIA 156 may replacecables connected between (i) the monitoring device 158 and (ii) thesensors 152. This eliminates wires traversing (extending from within tooutside) a sterile field in which a patient is located.

As another example, the WIA 156 may receive signals from the sensors152. The signals from the sensors 152 may indicate first parameters. TheWIA 156 and/or the procedure module 162 may determine second parametersbased on the received signals. The first parameters may include, forexample, voltages, frequencies, current levels, durations, amplitudes,temperatures, impedances, resistances, wavelengths, etc. The secondparameters may include, for example, durations, oxygen levels,temperatures, impedances, pH levels, accelerations, amplitudes, heartrates, blood pressures, electro-cardiogram (ECG) parameters, respiratoryparameters, body activity values, heart sounds, blood gas pH, red bloodcell counts, white blood cell counts, electro-encephologram (EEG)parameters, etc. The second parameters may be used to determine range ofmotion values, activity levels, pain levels, and/or other evaluatedparameters. The received signals and/or the determined information maybe forwarded to the monitoring device 158 for evaluation and/or fordisplay on the screen of the monitoring device 158.

The sensors 152 may be of various type and style. The sensors 152 may bepatch type sensors and/or may be implantable type sensors. One patchtype sensor is shown as being located on a chest of a patient in FIG. 3.Multiple implantable type sensors, which are located along, adjacent toand/or attached to a spine of the patient, are shown in FIG. 3. Thesensors may be incorporated in hardware (e.g., spinal hardware)implanted in the patient, such as in screws or other implantablehardware. Other types of sensors and/or configurations of the sensor 152may be incorporated in the wireless monitoring system 150. The sensors152 may include respective pins and/or needles that are inserted into,for example, muscle tissue of a patient. The sensors 152 may be adheredto skin of a patient over, for example, muscle tissue.

The sensors 152 may continuously monitor activity and quality of sleepand as a result perform as surrogate sensors for RoM and pain. Thesensors 152 may be leveraged for Pre-Op baseline determination andPost-Op outcome determination. As a couple of examples, the activity maybe characterized as sedentary, light, medium, vigorous and/or may beindicated as a score between 1-10. The RoM may be based on referencepoints (or landmarks) and known spacing between the reference points.Vital signs such as heart rate and respiration rate may be monitored.The sensors 152 may include an interface and/or display for interactionwith a user.

The sensors 152 may include accelerometers, temperature sensors, and/orother non-intrusive sensing elements. The accelerometers may includepiezoelectric elements and perform low-pass filtering on generatedsignals. The sensors 152 may, for example, be used to detect the firstparameters including voltage potentials and/or current levels passedbetween electrodes and/or pins of the sensors 152. The sensors 152 maybe intrusive or non-intrusive sensors. The intrusive sensors may includeone or more arrays of pins and/or needles for insertion into thepatient. The non-intrusive sensors may include electrodes that rest onthe skin of the patient and/or other sensing elements. Voltagepotentials, impedances, and/or current levels between selected pairs ofthe pins, electrodes and/or needles may be monitored. This may includemonitoring various pin, electrode, and/or needle combinations in asingle array and/or pin, electrode, and/or needle combinations of pinselectrodes, and/or needles in different arrays. For example, a voltagepotential between a first pin, electrode and/or needle in a first arrayand a second pin, electrode and/or needle in a second array may bemonitored. The sensors 152 may each include any number of pins,electrodes and/or needles. The sensors 152 may alert the CIM and/or themonitoring device 158 of nerve and/or muscle activity. The wirelessmonitoring system 150 may include any number of sensors and/orstimulation probe devices.

The wireless monitoring system 150 may also include a cloud (or network)166. The cloud 166 may include a server 168. The server 168 may belocated at a call center and/or be in communication with a call center.The communication may be via wires or a wireless link (e.g., a nearfield communication (NFC) telemetry link) may include a way station, anInternet link, a cell phone network connection, a universal serial bus(USB) connection, and/or other connections. The server 168 and/or callcenter may be centrally located and monitor information from the sensors152 and/or information generated and/or provided by the monitoringdevice 158. The server 168 may communicate with the monitoring device158. This communication may include transfer of data collected from thesensors 152 and/or other information collected via the systems of FIGS.1-2B. For example, sensor data and/or image data may be provided by themonitoring device 158 to the server 168. The server 168 may analyze thedata and feedback results of the analysis to the monitoring device 158or the monitoring device 158 and/or CIM 202 may perform the analysis.The analyzing of the data may include motion/displacement measurements,spinal instability and/or alignment values/scores, RoM and/or painscores, cumulative RoM and/or pain scores, overall combined scores,probabilities of a successful outcome of one or more procedures, etc.Examples of how RoM and pain scores, cumulative RoM and pain scores, andoverall combined scores may be determined are further described belowwith respect to the embodiments of FIGS. 8-10. The results of theanalysis may be transmitted from the server 168 to the monitoring device158 and/or to other devices connected to and/or in a network of theserver 168. The monitoring device 158 and/or the other devices may beimplemented as cellular phones, tablets, computers, and/or other smartdevice. The sensors 152 may communicate with the other devices inaddition to communicating with the monitoring device 158. The otherdevices may then perform similar analysis of data collected from thesensors 152. The sensors 152 may be incorporated in one or more wearableitems that are worn on a patient (e.g., an adhesive bandage, a bracelet,cloths, etc.).

Referring now to FIGS. 3-4, which show a sensing module 200, a CIM 202and the monitoring device 158. The sensing module 200 wirelesslycommunicates with the CIM 202 and/or with the monitoring device 158 viathe CIM 202. The sensing module 200 may be included in any of thesensors disclosed herein including the sensors shown in FIG. 3. The CIM202 may be included in the WIA 156 of FIG. 3.

The sensing module 200 includes a control module 206 (e.g., amicroprocessor), a memory 208, and a physical layer (PHY) module 210(e.g., a transceiver and/or radio). The control module 206 detects (i)signals from non-intrusive sensing elements 211, (ii) electromyographicsignals generated in tissue of a patient via sensing elements 212 (e.g.,pins, needles, electrodes, and/or flexible circuit with electrodes),(iii) voltage potentials, current levels, and/or impedances betweenselected pairs of the sensing elements 212. The electromyographicsignals may be in the form of voltage signals having voltage potentials.One or more of the voltage signals and/or current levels may be fromphotodiodes and/or photodetectors, which may be included in the sensingelements 212. The control module 206 may also drive illuminating devices214 (e.g., lasers, light emitting diodes (LEDs), etc.). The voltagesignals and/or current levels generated via the photodiodes and/orphotodetectors may be light emitted by the illuminating devices 214 andreflected off of tissue of a patient and detected by the photodiodesand/or photodetectors. The photodiodes may be used to detect colorand/or wavelength of reflected light. Oxygen content levels may bedetermined based on amplitudes of the voltage signals generated by thephotodiodes.

The control module 206 includes a front end receive module 216, a frontend transmit module 218, and a baseband module 220. The front endreceive module 216 may include one or more of each of an amplifier, amodulator, a demodulator, a filter, a mixer, a feedback module, and aclock. The front end transmit module 218 may include one or more of eachof a modulator, an amplifier, and a clock. The baseband module 220 mayinclude an upconverter and a downconverter. The front end receive module216 may modulate, demodulate, amplify, and/or filter signals receivedfrom the sensing elements 211, 212 prior to generating an output for thebaseband module 220. The front end transmit module 218 may transmitstimulation signals to selected ones of the sensing elements 212 (e.g.,selected pins and/or needles) and/or control operation of theilluminating devices 214. The front end transmit module 218 may modulatestimulation signals provided to the sensing elements 212 and/or modulateillumination signals generated by the illuminating devices 214.Stimulation signals and/or illumination signals may not be modulated.

The filtering performed by the front end transmit module 218 may includebandpass filtering and/or filtering out (i) frequencies of the amplifiedsignals outside of a predetermined frequency range, and (ii) a directcurrent (DC) voltage. This can eliminate and/or minimize noise, such as60 Hz noise. The front end receive module 216 generates baseband signalsbased on the signals received by the front end receive module 216.

The baseband module 220 may include an analog-to-digital (A/D)converting module 230 (e.g., an A/D converter) and convert the basebandsignals (analog signals) to digital baseband (BB) signals. The BB module220 and/or the A/D converting module 230 may sample the output of thefront end receive module 216 at a predetermined rate to generate frames,which are included in the digital BB signals. By A/D converting signalsat the sensor as opposed to performing an A/D conversion at the CIM 202or the monitoring device 158, opportunities for signal interference isreduced. The BB module 220 may include a multiplexer 232 formultiplexing (i) signals generated by the front end receive module 216,and/or (ii) generated based on the signals generated by the front endreceive module 216.

The BB module 220 may then upconvert the digital BB signal to anintermediate frequency (IF) signal. The BB module 220 may performdirect-sequence spread spectrum (DSSS) modulation during upconversionfrom the digital BB signal to the IF signal. The BB module 220 mayinclude a mixer and oscillator for upconversion purposes. The BB module220 and/or the control module 206 may compress and/or encrypt BB signalstransmitted to the PHY module 210 prior to upconverting to IF signalsand/or may decompress and/or decrypt signals received from the PHYmodule 210. The PHY module 210 may communicate with other electronicdevices using near field communication protocols.

The BB module 220 may provide a received signal strength indication(RSSI) indicating a measured amount of power present in a RF signalreceived from the CIM 202. This may be used when determining which ofmultiple CIMs the sensor is to communicate with. The control module 206may select a CIM corresponding to a SYNC request signal and/or a payloadrequest signal having the most power and/or signal strength. This mayinclude (i) selecting a channel on which the SYNC request signal and/orthe payload request signal was transmitted, and (ii) communicating withthe CIM on that channel. This allows the control module 206 to selectthe closest and proper CIM. This selection may be performed when thesensor has not previously communicated with a CIM, is switching to adifferent WNIM network, and/or has been reset such that the sensor doesnot have a record of communicating with a CIM. In one embodiment, thesensors are unable to be reset.

The memory 208 is accessed by the control module 206 and stores, forexample, parameters 240. The parameters 240 may include parametersprovided in SYNC request signals and/or parameters associated withsignals generated via the sensing elements 211, 212. The parameters mayinclude parameters determined by the control module 206. The parametersstored in the memory 208 may include voltages, current levels,amplitudes, peak magnitudes, pulse durations, temperatures, pH levels,frequencies, impedances, resistances, oxygen levels, perfusion and/orconduction rates, accelerations, heart rates, blood pressures, ECGparameters, respiratory parameters, body activity values, heart sounds,blood gas pH, red blood cell counts, white blood cell counts, EEGparameters, etc.

The PHY module 210 includes a transmit path 242 (or transmitter) and areceiver path 246 (or receiver). The transmit path 242 includes amodulation module 248 (e.g., a modulator) and an amplification module250 (e.g., an amplifier). The modulation module 248 modulates andupconverts the IF signal to generate a radio frequency (RF) signal. Thismay include Gaussian frequency-shift keying (GFSK) modulation. Themodulation module 248 may include, for example, a filter, a mixer, andan oscillator (collectively identified as 252). The amplification module250 may include a power amplifier 254, which amplifies the RF signal andtransmits the RF signal via the antenna 256.

The receiver path 246 includes a second amplification module 260 and ademodulation module 262 (e.g., a demodulator). The amplification module260 may include a low-noise amplifier (LNA) 264. The secondamplification module 260 amplifies RF signals received from the CIM 202.The demodulation module 262 demodulates the amplified RF signals togenerate IF signals. The IF signals are provided to the BB module 220,which then downconverts the IF signals to BB signals. The demodulationmodule 262 may include, for example, a filter, a mixer, and anoscillator (collectively identified as 266). The A/D converting module230 may include a digital-to-analog (D/A) converter to convert the BBsignals to analog signals. The RF signals received from the CIM 202 mayinclude, for example, SYNC request signals or portions thereof.

The CIM 202 includes a PHY module 300, a control module 302, a memory304, and the interface 163 (e.g., 32 pin connector). The PHY module 300includes a receive path (or receiver) 308 and a transmit path (ortransmitter) 310. The receive path 308 includes an amplification module312 and a demodulation module 314. The amplification module 312amplifies RF signals received from the sensing module 200 and/or fromother sensor modules. The amplification module 312 may include a LNA315. The demodulation module 314 demodulates and downconverts theamplified RF signals to generate IF signals. The demodulation module 314may include a filter, mixer, and an oscillator (collectively referred toas 317). The transmit path 310 includes a modulation module 316 and anamplification module 318. The modulation module 316 modulates andupconverts IF signals from the control module 302 to generate RFsignals. This may include Gaussian frequency-shift keying (GFSK)modulation. The modulation module 316 may include, for example, afilter, a mixer, and an oscillator (collectively identified as 319). Theamplification module 318 transmits the RF signals to the sensing module200 via an antenna 320 and/or to other sensor modules and/or stimulationprobe devices. The amplification module 318 may include a poweramplifier 321.

The control module 302 includes a BB module 324 and a filtering module326. The BB module 324 converts IF signals received from the PHY module300 to BB signals and forwards the BB signals to the filtering module326. The BB module may demultiplex an IF signal and/or a BB signal toprovide multiple IF signals and BB signals. The BB module 324 alsoconverts BB signals from the filtering module 326 to IF signals, whichare forwarded to the modulation module 316. The BB module 324 mayinclude a D/A converting module 328, a demultiplexer 329, and/or a fastFourier transform (FFT) module 331.

The D/A converting module 328 may include an A/D converter to convertanalog signals from the filtering module 326 to digital signals. The D/Aconverting module 328 may include a D/A converter to convert digitalsignals from the PHY module 300 to analog signals. In one embodiment,the BB module 324 does not include the D/A converting module 328 anddigital signals are passed between the filtering module 326 and the PHYmodule 300. The demultiplexer 329 may demultiplex the analog signalsand/or the digital signals. The FFT module 331 performs a FFT of theanalog signals and/or the digital signals for spectral waveform analysisincluding frequency content monitoring.

The BB module 324 may attenuate signals received from the demodulationmodule 314. The filtering module 326 may be a bandpass filter and removefrequencies of signals outside a predetermined range and/or DC signals.This can eliminate and/or minimize noise, such as 60 Hz noise. The BBmodule 324 and/or the control module 302 may compress and/or encryptsignals transmitted to the modulation module 316 and/or decompressand/or decrypt signals received from the demodulation module 314.Although the CIM 202 is shown as being connected to the monitoringdevice 158 via the interface 163, the CIM 202 may be separate from themonitoring device 158 and wirelessly communicate with the monitoringdevice 158 via the PHY module 300.

The memory 304 is accessed by the control module 302 and stores, forexample, parameters 330. The parameters 330 may include parametersprovided in SYNC request signals and/or parameters indicated in and/orgenerated based on the signals received via the sensing elements 211,212. The parameters 330 may include The parameters stored in the memory208 may include voltages, current levels, amplitudes, peak magnitudes,pulse durations, temperatures, pH levels, frequencies, impedances,resistances, oxygen levels, perfusion and/or conduction rates,accelerations, heart rates, blood pressures, ECG parameters, respiratoryparameters, body activity values, heart sounds, blood gas pH, red bloodcell counts, white blood cell counts, EEG parameters, etc. and mayinclude or be the same as the parameters 240. The memory 304 may alsostore synchronization requests 332, which are defined below.

The monitoring device 158 may include a control module 340, a PHY module342, a CIM interface 344, a display 346 and a memory 348. The controlmodule 340: generates payload request signals; receives data payloadsignals from the sensing module 200 and/or other sensing modules andstimulation probe devices via the CIM 202; and displays signals and/orother related information on the display 346. The displayed signalsand/or information may include the parameters 330 and/or informationgenerated based on the parameters 330. The PHY module 342 may transmitsignals to and receive signals from the control module 340 via theinterfaces 163, 344 as shown or wirelessly via an antenna (not shown).The memory 348 is accessed by the control module 340 and stores theparameters 330 and may store payload requests 350, which are definedbelow. The control module 302 and/or the control module 340 may includethe procedure module 162.

The control modules 206, 326, the BB modules 220, 324, the PHY modules210, 300, and/or one or more modules thereof control timing of signalstransmitted between the sensing module 200 and the CIM 202. The PHYmodules 210, 300 may communicate with each other in a predeterminedfrequency range. As an example, the PHY modules 210, 300 may communicatewith each other in 2.0-3.0 giga-hertz (GHz) range. In one embodiment,the PHY modules 210, 300 transmit signals in a 2.4-2.5 GHz range. ThePHY modules 210, 300 may communicate with each other via one or morechannels. The PHY modules 210, 300 may transmit data at predeterminedrates (e.g., 2 mega-bits per second (Mbps)). The CIM 202 and/or themonitoring device 158 may set the frequency range, the number ofchannels, and the data rates based on: the number of sensor modules inand actively communicating in the wireless monitoring system 150; thetypes of the sensors; the number of channels per sensor; and/or thespeed per channel of each of the sensors.

Referring now to FIG. 3 and FIG. 5, which shows the sensing module 200and a monitoring device 350. The sensing module 200 includes the controlmodule 206, the memory 208 and the PHY module 210. The control module206 includes the front end receive module 216, the front end transmitmodule 218, and the BB module 220. The control module 206 receivessignals from the sensing elements 211, 212 and controls operation of theilluminating devices 214. The control module 206 reports data associatedwith the signals to the monitoring device 350 via the PHY module 210.The control module 206 also receives signals (e.g., synchronizationrequest signals) from the monitoring device 350 via the PHY module 210.

The monitoring device 350 includes a control module 352, a memory 354, aPHY module 356, and the display 358. Functionality of the CIM 202 ofFIG. 4 is included in the monitoring device 350. The PHY module 356includes a receive path 360 (or receiver) and a transmit path 362 (ortransmitter). The receive path 360 includes an amplification module 364and a demodulation module 366. The amplification module 364 via a LNA365 amplifies RF signals received from the sensing module 200 and/orfrom other sensor modules and/or stimulation probe devices. Thedemodulation module 366 demodulates and downconverts the amplified RFsignals to generate IF signals. The transmit path 362 includes amodulation module 368 and an amplification module 370. The modulationmodule 368 and the amplification module 370 may operate similar to themodulation module 316 and the amplification module 312. Theamplification module 370 may include a power amplifier 372 and transmitsRF signals via an antenna 373 to the sensing module 200 and/or to othersensor modules.

The control module 352 includes a BB module 374 and a filtering module376. The BB module 374 converts IF signals received from the PHY module356 to BB signals and forwards the BB signals to the filtering module376. The BB module 374 may demultiplex the IF signals and/or the BBsignals. The BB module 374 also converts BB signals from the filteringmodule 376 to IF signals, which are forwarded to the modulation module368. The BB module 374 may include a D/A converting module 378 and/or ademultiplexer 375. The D/A converting module 378 may include an A/Dconverter to convert analog signals from the filtering module 376 todigital signals. The demultiplexer 375 may demultiplex the analog and/orthe digital signals. The D/A converting module 378 may include a D/Aconverter to convert digital signals from the PHY module 356 to analogsignals. In one embodiment, the BB module 374 does not include the D/Aconverting module 378 and digital signals are passed between thefiltering module 376 and the PHY module 356. The BB module 374 mayattenuate signals received from the demodulation module 366. Thefiltering module 376 may be a bandpass filter and remove frequencies ofsignals outside a predetermined range and/or DC signals. This caneliminate and/or minimize noise, such as 60 Hz noise. The BB module 374and/or the control module 352 may compress and/or encrypt signalstransmitted to the modulation module 368 and/or decompress and/ordecrypt signals received from the demodulation module 366.

Referring now to FIGS. 3 and 5, the BB module 220 of the sensing module200 may provide a received signal strength indication (RSSI) indicatinga measured amount of power present in a RF signal received from themonitoring device 350. This may be used when determining which ofmultiple monitoring devices to communicate with. The control module 206may select a monitoring device corresponding to a SYNC request signaland/or a payload request signal that has the most power and/or signalstrength. This may include selecting a channel on which the SYNC requestsignal and/or the payload request signal was transmitted andcommunicating with the CIM 202 and/or the monitoring device 350 on thatchannel. This allows the control module 206 to select the closest andproper monitoring device. This selection may be performed when thecorresponding sensor has not previously communicated with the monitoringdevice 350 and/or other monitoring devices and/or has been reset suchthat the sensor does not have a record of communicating with themonitoring device 162 and/or other monitoring devices.

The memory 354 may store the parameters 330, payload requests 351 and/orthe SYNC requests 332. The memory 354 may store the SYNC requests 332and may not store the payload requests 351. This is because themonitoring device 350 may generate SYNC requests and not payloadrequests.

Referring now to FIGS. 3 and 6, which show a sensing module 400. Thesensing module 400 may be included in any of the sensors (e.g., thesensors 152 of FIG. 3) disclosed herein and/or replace any of thesensing modules (e.g., the sensing module 200 of FIGS. 4-5) disclosedherein. The sensing module 400 may include the control module 206, thePHY module 210, a power module 406, a power source 208, a temperaturesensing module 410, an A/D converter 412, and an accelerometer 414(e.g., a 3-axis accelerometer or 9-axis accelerometer) or other motionsensor (e.g., a gyro). The motion sensor 414 includes motion sensingelements (e.g., electrodes) 415 for generating a signal indicative ofmotion and/or acceleration. Although the sensing module 400 is shown ashaving the temperature sensing module 410, the sensing module 400 maynot include the temperature sensing module 410. The temperature sensingmodule 410 may be replaced with a temperature sensor, such as aninfrared temperature sensor. In one embodiment, the sensing module 400includes the temperature sensing module 410 and the temperature sensor.Although shown separate from the control module 206, the PHY module 210,the power module 406, the temperature sensing module 410 and/or the A/Dconverter 412 may be included in and as part of the control module 206.The sensing module 400 may include or be connected to other sensingelements 417.

The control module 206 includes the front end modules 216, 218 and theBB module 220 of FIG. 4. The PHY module 210 includes the modulationmodule 248, the demodulation module 262 and the amplification modules250, 260 of FIG. 4.

The control module 206, the PHY module 210, the temperature sensingmodule 410, and the A/D converter 412 operate based on power from thepower module 406. The power module 406 receives power from the powersource (e.g., a battery). The power module 406 may include a switch 416as shown (or a pull-tab) to turn ON and/or OFF the power module 406 andthus turn ON and/or OFF the sensing module 400 and/or the correspondingsensor. The switch 416 may be manually operated or may be operated bythe power module 406, the control module 206 and/or the PHY module 210.In one embodiment, the switch 416 is manually operated and at leastpartially exposed on an exterior of the sensing module 400 and/orcorresponding sensor housing. In another embodiment, the switch 416includes one or more transistors located in the control module 206, thePHY module 210, and/or in the power module 406, as shown. If included inone of the modules 206, 210, 406, the switch 416 is not exposed on anexterior of the sensing module 400 and/or the corresponding sensorhousing. The state of the switch 416 may be controlled by the controlmodule 206, the PHY module 210, and/or the power module 406 based onsignals received from sensing elements 211, 212, the CIM 202, and/or themonitoring device 350 of FIGS. 4-5. The sensing elements 211 may includethe temperature sensing module 410 and the motion sensor 414.Transitioning the switch 416 via one of the modules 206, 210, 406 from afirst state to a second state to turn ON at least a portion of thesensor and/or at least a portion of the one or more of the modules 206,210, 406 may be referred to as an “auto-start”.

The sensing module 400 may operate in: a high power mode (fully poweredmode), a low (or idle) power mode (partially powered or transmittingless frequently then when in the high power mode), a sleep mode, or OFF.Operation in and transition between these modes may be controlled by oneor more of the modules 206, 210, 406. As an example, the sensor may beOFF (or dormant) while being shipped and/or not in use. The sensor mayalso be OFF if: not yet communicated with a CIM and/or monitoringdevice; a connection has not yet been established between the sensingmodule 400 and a CIM and/or monitoring device; the sensor has not yetbeen assigned to a CIM and/or monitoring device; and/or the sensor hasnot yet been assigned one or more time slots in which to communicatewith a CIM and/or monitoring device.

Transitioning to the low power mode, the sleep mode and/or to OFFdecreases power consumption and can aid in minimizing size of the powersource 408. The power source may include a solid-state rechargeablepower source. While partially powered, the control module 206 and/orportions of the control module 206 and the PHY module 210 may bedeactivated. The receiver path of the PHY module 210 may remainactivated to (i) receive signals from the CIM 202 and/or portions of thecontrol module 206, and (ii) detect signals from the sensing elements211, 212. The transmit path 242 of the PHY module 210 and/or otherportions of the sensor that are not experiencing activity may bedeactivated. Transitioning between the stated modes is further describedbelow.

Referring again to FIGS. 3 and 6, one or more of the sensors 152 mayinclude a temperature sensing module (e.g., the temperature sensingmodule 410) and/or a motion sensor (e.g., an accelerometer, a gyrosensor, or the motion sensor 414). By including temperature sensingmodules in sensors, temperatures of various points on a patient may bemonitored.

The temperature sensing module 410 may include a first transistor 420and a second transistor 422. The first transistor 420 may betransitioned between states to supply current to the second transistor422. This turns ON the temperature sensing module 410. The secondtransistor 422 is configured to detect a temperature. As an example, thefirst transistor 420 may be a metal-oxide-semiconductor field-effecttransistor (MOSFET) and includes a drain, a gate and a source. Thesecond transistor 422 may be a bipolar junction transistor (BJT) andincludes a collector, a base and an emitter. The transistors 420, 422are shown for example purposes only, one or more of the transistors 420,422 may be replaced with other transistors or other similarly operatingcircuitry. The drain is connected to and receives current from the powermodule 406. The gate is connected to and receives a control signal fromthe control module 206. The source of the first transistor 420 isconnected to the collector and the base. The collector is connected to aground terminal 424. The collector and the emitter are also connected tothe A/D converter 230.

The second transistor 422 is connected in a diode configuration.Temperature dependence of the base-to-emitter voltage (Vbe) is the basisfor temperature measurement. The base-to-emitter voltage Vbe isdependent on temperature while (i) the power source 408 and the powermodule 406 supply a constant level of current to the collector via thefirst transistor 420, and (ii) a voltage across the base and thecollector is zero. The voltage across the base (or collector) and theemitter is detected by the A/D converter. The detected voltage isconverted to a temperature via the control module 206. The controlmodule 206 based on a digital signal output by the A/D converter 230,determines the temperature. The temperature may be determined using, forexample, expression 1, where A is a predetermined multiplier constantand B is a predetermined offset constant.A·Vbe+B  [1]

In addition to detecting signals from the sensing elements 211, 212 andtemperature, the sensing module 400 may also detect other parameters,such as heart rate, respiration rate, and/or muscle spasms. Theseparameters may be determined via one or more of the control modules 206,302, 340, 326 of the sensor, the CIM 202 and the monitoring devices 158,350 of FIGS. 3-5. The monitoring devices 158, 350 may generate an alertsignal and/or display these parameters on the display 358. Thisinformation may also be used to provide an early indication that apatient is coming out from anesthesia prematurely. The sensing elements211, 212 may be monitored for EMG purposes as well as for heart rate,respiration rate, and/or muscle spasms purposes. To detect thisinformation, the sensor may be attached to (or mounted on) a trunk of apatient or may be implanted in the patient.

A heart rate may be in a same frequency band as an electromyographicsignal. A heart rate is periodic unlike an electromyographic signal. Avoltage potential detected as a result of a beating heart may have alarger amplitude (or magnitude) than amplitudes (or magnitudes) of anelectromyographic signal. A respiration rate is typically in a lowerfrequency band than an electromyographic signal. A muscle spasm may havea distinguishable frequency and/or distinguishable frequency band. Thus,one or more of the control modules 206, 302, 340, 326 may distinguishbetween signals or portions of signals corresponding to a heart rate, arespiration rate, and an electromyographic signal based on thesedifferences. If the control module 206 of the sensor detects heart rate,respiration rate, and/or muscle spasms, the control module 206 maywirelessly transmit this information to the CIM 202 and/or one of themonitoring devices 158, 350. The monitoring devices 158, 350 may thendisplay this information and/or generate an alert signal if one or moreof these parameters are outside of respective predetermined rangesand/or thresholds.

In addition to or as an alternative to monitoring the sensing elements211, 212 to detect heart rate, respiration rate, and/or muscle spasms,the sensor includes a motion sensor. As similarly described above, oneor more of the control modules 206, 302, 340, 326 may monitor signalsfrom the motion sensor (e.g., acceleration signals generated by anaccelerometer) to detect activity of muscle firing, heart rate,respiration rate, and/or muscle spasms. The acceleration information,muscle firing activity, heart rate, respiration rate, and/or musclespasm information determined based on the acceleration signals may bewirelessly transmitted from the sensor and/or PHY module 210 to the CIM202 and/or one of the monitoring devices 158, 350.

The sensor may “self-awake”. In other words, the sensor mayautomatically transition from being OFF or being in the low power (orsleep) mode to being powered ON and being in the high power mode whenattached to a patient. For example, while not attached to a patient,there is an “open” circuit between two of the sensing elements 212.Thus, an impedance between two of the sensing elements 212 is high(e.g., greater than 10 kilo-Ohms (kOhms)). Subsequent to attaching thesensor to the patient, an impedance between the two of the sensingelements 212 is low (e.g., less than 1 kOhms) and/or significantly lessthen when the sensor was not attached. This difference in impedance canbe detected and cause the power module 406 and/or the control module 206to switch operating modes.

In another embodiment, the two of the sensing elements 212 andcorresponding impedance between the two of the sensing elements 212operate as a switch to activate the power module 406. Upon activation,the power module 406 may supply power to the control module 206 and/orthe PHY module 210.

In yet another embodiment, the power module 406 (or analog front end) isconfigured to generate a DC voltage while the sensor is not attached toa patient. Generation of the DC voltage may be based on the impedancebetween the two of the sensing elements 212. This DC voltage is detectedby the control module 206. The control module 206 remains in the lowpower (or sleep) mode while receiving the DC voltage. The power module406 ceases to provide the DC voltage when the electrodes are attached tothe patient. This causes the control module to transition (i) from beingOFF to being in the low power mode or high power mode, or (ii) frombeing in a sleep mode to being in the low power mode or the high powermode.

The control module 206 and/or the power module 406 may periodicallytransition between operating in a low power (or sleep) mode and the highpower mode to check the impedance between the two of the sensingelements 212 and whether the DC voltage is provided. This may occurevery predetermined period (e.g., 30-60 seconds). In another embodiment,in response to the two of the sensing elements 212 being attached to apatient, the power module 406 may transition (i) from not supplyingpower to the control module 206, the PHY module 210 and/or portionsthereof to (ii) supplying power to the control module 202, the PHYmodule 210 and/or portions thereof.

Although the modules 210, 406, 410 and the A/D converter 230 are shownas being separate from the control module 206, one or more of themodules 210, 406, 410 and the A/D converter 230 or portions thereof maybe incorporated in the control module 206. Signal lines 421 are shownbetween the sensing elements 212 and the control module 202. A thirdsignal line may be included for noise feedback cancellation.

The sensing elements 211 may include other sensors and/or sensingelements 450, such as one or more of each of an infrared sensingelement, a pH sensor, a sensing array, a photodiode detector, etc. Inone embodiment, the pins of the sensing arrays are used to detectvoltages, current levels, impedances, and/or resistances. In anotherembodiment, one of the sensing arrays is used to detect voltages,current levels, impedances, and/or resistances while the other sensingarray is used to provide stimulation pulses. In yet another embodiment,selected pins of each of the sensing arrays are used to detect voltages,current levels, impedances, and/or resistances while the same and/orother selected pins of the sensing arrays are used to providestimulation pulses.

The infrared sensing elements (e.g., diodes capable of detectinginfrared energy) may be part of an infrared temperature sensor anddetect temperature of tissue and generate temperature signals indicativeof the temperature. The infrared temperature sensor may detect infraredenergy emitted from the tissue within a predetermined infrared band. Asa nerve is decompressed, perfusion occurs, which increases blood flowand oxygen levels and as a result increases temperature of the tissue ofand around the nerve. Thus, the temperature of the tissue is indicativeof the state of decompression and/or level of perfusion of the tissue.In addition or as an alternative to the infrared temperature sensor aheat sensitive camera may be used to monitor small temperature changesassociated with changes in perfusion.

The pH sensor (or neuropathy sensor) may include a needle and a flexcircuit. The pH sensor detects pH levels in tissue of a patient. Theneedle may be inserted in the tissue when the sensor is attached to thetissue. The needle guides the flex circuit into the patient. The flexcircuit may include pH sensing elements (e.g., electrodes 319) betweenwhich current is supplied. The flex circuit performs electrochemicalimpedance spectroscopy techniques to measure pH levels of target tissue.This may include supplying current to the electrodes and monitoringchanges in conductivity levels of the tissue. Presence of differentchemicals in the tissue changes impedance of the tissue and as a resultconductivity of the tissue. For example, if tissue of a patient exhibitspoor perfusion, the patient may develop neuropathy (or diabeticneuropathy due to lack of blood flow), which includes accumulation ofnitrous oxide and associated chemicals with nitrogen. This results in anacidic reaction that is directly related to a pH level, which can bedetected using the flex circuit.

The sensing array may include a vertical-cavity surface-emitting laser(VCSEL) and a photodiode detector (or other light detecting device) orother optical and/or perfusion sensor. The VCSEL and the photodiodedetector may be used to detect changes in wavelength of light reflectedoff of tissue and/or blood. The changes in wavelength correspond tochanges in color, which relates to changes in blood flow, pressure ofblood flow, and/or oxygen levels in the blood. As more blood flows thepressure of the blood flow increases, which provides an increase in apulsified amplitude of a received signal. As another example, the morered the color of the reflected light, the more blood flowing in thetissue.

In addition to being used to detect the above-stated parameters, one ormore of the pins may be used to detect temperature of tissue within thepatient. Thus, each of the pins may be used for multiple purposes. Thepins may be used for nerve integrity monitoring, perfusion monitoring,decompression monitoring, etc. Impedance of tissue changes duringperfusion. This may be detected using the pins. Different sets of thepins may be used for different purposes or each set of the pins may beused for all of the stated purposes. The pins may be inserted inmuscle/tissue being monitored. Each of the pins may be used formonitoring one or more parameters. In one embodiment, a respectivenumber of pins are allocated for each parameter monitored. Eachparameter monitored may have a same or different number of allocatedpins.

Additional details of the wireless protocol are described below withrespect to FIG. 7. FIG. 7 shows a signal flow diagram illustrating asensor 500 joining a WNIM network and communicating in a WNIM systemwith a CIM and/or a monitoring device (collectively designated 502). Thesensor 500 may refer to any sensor disclosed herein. Similarly, the CIMand/or monitoring device 502 may refer to any CIM and/or monitoringdevice disclosed herein. Before a sensor responds to a SYNC request witha data payload, a joining process is performed. Joining establishes alink between the sensor and a CIM and/or monitoring device and togetherthe sensor and the CIM and/or monitoring device (and/or other sensorsand/or stimulation probe devices linked to the CIM and/or monitoringdevice) provide a WNIM network. FIG. 7 shows an example sequence ofevents performed for the sensor 500 to join the WNIM network and alsohow different modes of operation are obtained.

A SYNC request signal 504 is transmitted from the CIM and/or NIM device502 and includes a word for each time slot in a corresponding SYNCinterval and is periodically and/or continuously updated and transmittedto indicate the statuses of the slots. To join the WNIM network, thesensor 500 checks all the available slots and selects the time slot inwhich to transmit a data payload signal to the CIM and/or NIM device502. Prior to transmitting the data payload, the sensor 500 sends a joinrequest 506 to join the WNIM network and communicate in the selectedtime slot. The join request 506 may be transmitted in the selected timeslot and indicates a sensor unique identifier (SUID) of the sensor, theselected time slot, the type of the sensor, a minimum data rate, and/ora maximum data rate of the sensor. In one embodiment, the sensor 500sends the SUID in the selected time slot and the CIM and/or NIM device502 has a record of the type and data rates of the sensor.

Based on the join request 506, the CIM and/or NIM device 502 fills anappropriate slot status word with the SUID from the sensor 500. The CIMand/or NIM device 502 may then send an updated SYNC request 508 with theupdated slot status word indicating designation of the selected timeslot to the sensor 500. The sensor 500 receives the updated SYNC requestwith the SUID in the corresponding slot status word and responds bysending a data payload to the CIM and/or the NIM device 502 in theselected slot. If more than one slot is selected and/or designated tothe sensor 500, the sensor 500 may transmit one or more data payloads inthe slots selected and/or designated to the sensor 500 (data payloads inslot 1 are designated 510 and data payloads in other slots aredesignated 511). The time slots may be associated with one or morechannels of the sensor 500. The transmission of the SYNC requests andthe data payloads may be periodically transmitted over a series ofperiodic SYNC intervals (or RF frames).

Once linked to the CIM and/or NIM device 502, the sensor 400 may now becontrolled by the CIM and/or NIM device 502 via transmission of updatedSYNC requests. The CIM and/or NIM device 502 may control, for example,output data rates and transitions between power modes of the sensor 500.As an example, the CIM and/or NIM device 502 may update the output datarate from 10 kHz to 5 kHz for the time slot of the sensor 500 bytransmitting an updated SYNC request 512. Sensors linked to the CIMand/or NIM device 502 inspect control bits (e.g., bits of the slotstatus words) in SYNC requests to determine respective operating and/orpower modes. The sensors then transition to the indicated operatingand/or power modes.

As described above, the CIMS, NIM devices, and sensors disclosed hereinmay communicate with each other using bits within payload requests,SYNCH requests, data payloads, and response signals. The CIMS and/or NIMdevices may initiate communication by a sending a payload request (SYNCrequest). The data payload may include one 16-bit word for payloadvalidation. The 16 bit-word may include a SUID. When the CIM and/or NIMdevice receives a data payload, the CIM and/or NIM device compares theSUID with an expected SUID stored in memory of the CIM and/or NIMdevice. The SUID may have been stored in the memory when the sensorjoined the corresponding WNIM network. If the comparison indicates amatch, the data in the data payload may be displayed at the NIM device.

Likewise, when the sensor receives the SYNC request, the sensor comparesa console unique identifier (CUID) of the CIM and/or NIM device providedin the SYNC request with an expected CUID stored in a memory of thesensor. The CUID may have been stored in the memory when the sensorjoined the corresponding WNIM network. If the comparison of the CUIDsindicates a match, the sensor may respond, depending on mode status bitswithin a slot status word of the SYNC request, with one or more datapayloads in the appropriate time slots following the SYNC request. Themode status bits may be the bits of the slot status word indicating adata rate and/or whether a stimulation pulse is to be generated.

Range of Motion (RoM) and Pain Monitoring

RoM and pain are key variables for determining successful spinal surgeryoutcomes. RoM is a surrogate for patient activity. Pain is a surrogatefor quality of sleep (QoS). RoM may be measured via imaging andmeasuring vertebrae displacement and/or curvature, for example, usingthe procedural operating system 15 and/or the spinal kinematics systemof FIGS. 2A, 2B and generating a RoM score based on the measuredvertebra displacements. Displacement of each vertebra of a spine may bemeasured relative to one or more reference points. The reference pointsmay be marked or unmarked. Curvature of the spine may refer to (i) asize of a radius of an arc formed by the curvature of the spine, and/or(ii) how uniform the curvature of the spine is fromvertebra-to-vertebra. As another example, the RoM score may be generatedbased on information received from the motion sensor 414 of FIG. 6. Forexample, outputs of one or more 3-axis or 9-axis accelerometers and/orother motion sensors may be used to determine an activity level,posture, and vertebrae positions over time. Output of the accelerometersmay be integrated twice to provide position information. The RoM scoremay also be based on an ECG value, a respiration rate (RR),beats-per-minute (bpm) of a heart, heart rate variability, etc. Anamount of pain may be indicated as a stress score, which may begenerated based on sleep interruption (number of sleep interruptionswithin a predetermined period), ECG (heart rate variability) over thepredetermined period, and respiration rates over the predeterminedperiod.

FIG. 8 shows an example of a portion of a control module 548 (e.g. oneof the control modules 302, 340, 352 of FIGS. 4-6). The control module548 may include a posture module 550, a prone module 552, a spinalmodule 553, an activity and/or RoM module 554, a QoS and/or pain module556, a first cumulative module 558, a second cumulative module 560, anda combined overall module 562. These modules are further described belowwith respect to the methods of FIGS. 9-10.

For further defined structure of the modules of FIGS. 1-6 and 8 seebelow provided methods of FIGS. 9-10 and below provided definition forthe term “module”. The systems, devices and modules disclosed herein maybe operated using numerous methods, in addition to the methods describedabove, some additional example methods are illustrated in FIGS. 9-10. InFIG. 9, a Pre-Op method is shown. Although the following tasks areprimarily described with respect to the implementations of FIGS. 1-6 and8, the tasks may be easily modified to apply to other implementations ofthe present disclosure. The tasks may be iteratively performed.

The methods may be performed for different levels of complexity,examples of which are referred to below as low, medium, and highcomplexity operating modes. The low complexity operating mode includescollecting data from a small set of one or more physiological sensorsand/or sensing modules (e.g., one or more 3-axis sensors and/or one ormore 9-axis sensors) for activity, posture, RoM and pain determinations.The medium complexity operating mode may include a larger set ofphysiological sensors and/or sensing modules (e.g., one or more 3-axissensors, one or more 9-axis sensors, one or more respiration sensors,and one or more ECG sensors for heart rate and heart rate variability)for RoM and pain determinations. Outputs of the medium complexity modesensors may be used for calculating stress scores. The additionalsensors used for the medium complexity mode provide increased accuracyin determining the below-described scores. The medium complexity modemay include detecting signals from any of the sensors disclosed hereinand determining any of the parameters disclosed herein.

The high complexity operating mode includes collecting data from sensorsused during the medium operating mode as well as capturing x-ray imagesof the patient, which may be used to determine activity, RoM, spinalinstability and alignment scores. The sensors and/or sensing modulesused during the above-stated low, medium and high complexity modes mayinclude, for examples, the sensors and/or sensing modules of FIGS. 3-6.RoM and pain scores may be determined based on the spinal instabilityand alignment scores as well as the information collected from thesensors. Spinal instability occurs when a vertebra slips from a normalalignment and can be painful. A spinal instability score may indicateand/or be based on an amount of displacement of a first vertebrarelative to one or more adjacent vertebrae. A spinal instability may bea leading indication for spine fusion surgery and for this reason may beweighted heavily when determining the RoM and/or pain scores. Separateor combined scores may be determined for spinal instability and spinalalignment.

The method may begin at 600. At 602, the control module 548 may performa Pre-Op protocol. This may include collecting sensor data from sensors(e.g., the sensors 152 of FIG. 3). This may also include capturing x-rayimages magnetic resonance imaging (MRI) images of the patient, dependingon whether the corresponding wireless imaging system is operating in thehigh complexity operating mode. The images may be, for example, of aspine of the patient.

At 604, the posture module 550 determines a posture of the patient basedon (i) signals from the sensors (e.g., the sensors 152) and/orcorresponding sensor modules, and/or (ii) the x-ray images.Ortho-imaging via a C-arm or O-arm® and corresponding quantitative dataanalysis may alternatively or also be performed to determine posture. At606, the spinal module 553 determines an instability and/or alignmentscore as described above depending on whether operating in the highcomplexity mode.

At 608, the prone module 552 determines whether the patient is in aprone (or lying down) state based on the posture determined at 604. Ifthe patient is not in a prone state, the patient is determined to beawake and active state and task 610 is performed. If the patient is in aprone state, the patient is determined to be in a rest or sleep stateand task 616 is performed.

At 610, the activity/RoM module 554 determines the activity of thepatient based on the information detected by and/or generated by thesensors. An activity score (e.g., 1-10) may be generated as describedabove. The accelerometers may be used as actigraph devices to monitorrest/activity cycles of the patient. The activity score may be generatedbased on the rest/activity cycles of the patient. While operating in thelow complexity mode, the activity may be based on the outputs of theaccelerometers. While operating in the medium or high complexity mode,the activity may be based on the outputs of the accelerometers and theother sensors. This may include measuring and/or determining heart rate,heart rate variability and other parameters.

At 612, activity/RoM module 554 determines a RoM score based on theactivity score for a current day (or period of time). An activity scoreprovides a baseline surrogate score for RoM and may be used to determinethe RoM score. FIG. 11 shows a table of Pre-Op and Post-Op RoM and Painscores. The table includes 10 example days of Pre-Op RoM percentages forranges of RoM scores. Weighted daily average scores are shown. Thehigher the daily average score, the greater the RoM (or more active) thepatient. Light activity refers to the range 0-2.5. Medium activityrefers to the range 2.6-5.0. High activity refers to the range 5.1-7.5.Vigorous activity refers to the range 7.6-10.

The activity score and/or the RoM score may be determined based onand/or as a function of information detected by the sensors includingECG ramp-rates, inter heart beat intervals, heart beats per minute, peakheart beats per minute, respiration ramp-rates, inter respiration beatintervals, peak inter respiration beat intervals, etc. As an example, asum of an activity score, an ECG score and a respiration score may bedetermined to provide a RoM score. The ECG score may be determined basedon and/or as a function of the ECG ramp-rates, inter heart beatintervals, heart beats per minute, and peak heart beats per minute. Therespiration score may be determined based on and/or as a function of therespiration ramp-rates, inter respiration beat intervals, and peak interrespiration beat intervals. At 614, the first cumulative module 558determines a cumulative RoM score. The cumulative RoM score may be a sumof the daily averaged RoM scores, as shown.

At 616, the QoS/pain module 556 may determine a number of sleepinterruptions during a sleep period and/or a QoS score. Theaccelerometers may be used as actigraph devices to monitor rest/activitycycles and determine an amount of sleep interruptions. Across-correlation between acceleration and velocity is an indicator ofspinal related pain. While operating in the low complexity mode, thenumber of sleep interruptions and/or the QoS score may be based on theoutputs of the accelerometers. While operating in the medium or highcomplexity mode, the number of sleep interruptions and/or a QoS scoremay be based on the outputs of the accelerometers and the other sensors.This may include measuring and/or determining heart rate, heart ratevariability and other parameters. The QoS score provides a baselinesurrogate score for pain. A low number of interruptions are shown by therange 0-2.5. A medium number of interruptions are shown by the range2.6-5. A high number of interruptions are shown by the range 5.1-7.5. Avery high number of interruptions are shown by the range 7.6-10. Each ofthe range values may refer to a number of interruptions per sleepperiod.

At 618, the QoS/pain module 556 determines a pain score (e.g., 1-10).FIG. 11 shows 10 days of Pre-Op pain/QoS percentages. Weighted dailyaverage scores for QoS/pain are shown. The higher the daily averagescore, the less pain (or better QoS) exhibited by the patient. A stressscore and/or pain score may be determined based on and/or as a functionof information detected by the sensors including number of sleepinterruptions, an ECG heart rate variability value, respirationramp-rates, inter respiration beat intervals, and peak inter respirationbeat intervals. The stress score may more of a neurological score,whereas the pain score may more of a physiological score. The ECG heartrate variability value indicates how much a heart rate changes over apredetermined period of time. As an example, the stress score may bedetermined based on a sum of the number of sleep interruptions, the ECGheart rate variability value, and the respiration score.

At 620, the second cumulative module 560 determines a cumulative stressand/or pain score is determined based on the weighted daily averagesand/or stress scores determined at 618. This may include summing theweighted daily averages of pain/QoS scores, as shown.

At 622, the combined overall module 562 determines a Pre-Op combinedscore based on the cumulative scores determined at 614, 620. An activityscore plus a QoS score provides a combined baseline surrogate score fora sum of a RoM score and a pain score. The Pre-Op combined score may bea sum of the cumulative scores, as shown in FIG. 11. The combined scoremay also be based on instability and/or alignment scores as determinedat 606.

At 624, the control module 548 may store any and/or all of theabove-stated scores in one of the memories 304, 348, 354 and/or transmitthe scores to server 168. These scores may be stored with other scoresfor other patients for a particular procedure. The instability and/oralignment scores may be stored separate from and/or in a differentmemory than the activity, RoM, QoS, pain, and/or cumulative scores.

At 626, the control module 206 may determine whether scores for anotherday or predetermined period are to be generated. If more scores are tobe generated, task 602 may be performed; otherwise task 628 may beperformed. The Pre-Op monitoring described above may be conducted for apredetermined period of time (e.g., 1 week) and may be monitored duringmost activities of daily life of the patient.

At 628, the control module predicts a likelihood (or probability) of apositive outcome for a procedure based on similar Pre-Op (orpre-procedure) scores and corresponding outcome scores. The Pre-Opscores and corresponding outcome scores may be stored in the server 168and/or in one or more of the memories 304, 348, 354. The server and thememories may store cut-points (or thresholds) for determining whether toperform the procedure. Differences between the above-determined scoresand other Pre-Op scores may be determined. If the differences are withinpredetermined ranges of and/or exceed the corresponding cut-points, andthe corresponding outcome scores are positive and/or there is a highprobability of a positive outcome, then performance of the procedure maybe recommended. The cut-points may be set based on probabilities that apositive outcome will result. For example, if a first cut-point ispassed, then a first probability of a positive outcome may be reported.If a second cut-point is passed, then a second probability of a positiveoutcome may be reported. The cut-points are different. Any number ofcut-points may be set and have corresponding probabilities of a positiveoutcome. The probabilities may be reported (e.g., displayed) via thecontrol module 206 and a corresponding display.

Ortho-imaging via a C-arm or O-arm and corresponding quantitative dataanalysis may alternatively or also be performed to evaluate spinalmobility for determining a probability of a positive outcome of asurgery. In one embodiment, the combined score, generated based on thecumulative scores, is compared to other Pre-Op scores. In anotherembodiment, the combined score, generated based on the cumulative scoresand the instability and alignment scores, is compared to other Pre-Opscores. In yet another embodiment, differences between one or both ofstated the combined scores and other Pre-Op scores are determined. Instill another embodiment, differences between the instability andalignment scores and other instability and alignment scores aredetermined. If the differences (for the combined score and/or theinstability and alignment scores) are within predetermined ranges ofand/or exceed corresponding cut-points, and the corresponding outcomescores are positive and/or there is a high probability of a positiveoutcome, then performance of the procedure may be recommended. Theabove-stated tasks thus include collecting data as a result ofphysiologic parameter monitoring and medical imaging and based oncorresponding cut-points determining a probability that execution of aprocedure will provide a positive outcome.

Task 628 may include determining if a surgery or procedure is bestchoice for a positive outcome. As an example, a current score for acurrent day may be indicative that surgery or procedure is not requiredand/or has a low probability of success. However, over time andcontinuous monitoring a patient with a spinal or degenerative diseasemay reveal that the scores have worsened and surgery would berecommended. The continuous monitoring and score determinations may beused to determine a best recommended time to perform the surgery toprovide a highest probability of success (i.e. highest probability thata positive outcome will result from performing the surgery).

The algorithm used to predict a likelihood of a positive (or negative)outcome may be considered a learning algorithm, as additional data iscollected the ability to accurately predict an outcome improves.

At 630, the control module performs task 632 if a negative outcome ispredicted. Task 634 is performed if a positive outcome is predicted. At632, the procedure may be adjusted or cancelled depending on the Pre-Opcombined score and/or the differences determined and/or comparisonsperformed at 628.

At 634, the control module may indicate that the procedure should beperformed. The method may end at 636 subsequent performing one of thetasks 632, 634.

FIG. 10 illustrates a Post-Op method in accordance with the presentdisclosure. The method of FIG. 10 is performed subsequent to performingthe method of FIG. 9 and a corresponding procedure. The method of FIG.10 may be performed a predetermined time period after performing theprocedure as a follow up check on results of the procedure. For example,the method of FIG. 10 may be performed 30 days, 60 days and/or 90 daysafter performing the procedure.

The method may begin at 650. At 652, the control module 548 may performa Post-Op protocol. This may include collecting sensor data from sensors(e.g., the sensors 152 of FIG. 3). This may also include capturing x-rayimages magnetic resonance imaging (MRI) images of the patient, dependingon whether the corresponding wireless imaging system is operating in thehigh complexity operating mode. The images may be, for example, of thespine of the patient.

At 654, the posture module 550 determines a posture of the patient basedon (i) signals from the sensors (e.g., the sensors 152) and/orcorresponding sensor modules, and/or (ii) the x-ray images.Ortho-imaging via a C-arm or O-arm® and corresponding quantitative dataanalysis may alternatively or also be performed to determine posture. At656, the spinal module 553 may determine an instability and/or alignmentscore as described above depending on whether operating in the highcomplexity mode.

At 658, the prone module 552 determines whether the patient is in aprone (or lying down) state based on the posture determined at 654. Ifthe patient is not in a prone state, the patient is determined to beawake and active state and task 660 is performed. If the patient is in aprone state, the patient is determined to be in a rest or sleep stateand task 666 is performed.

At 660, the activity/RoM module 554 determines the activity of thepatient based on the information detected by and/or generated by thesensors. An activity score (e.g., 1-10) may be generated as describedabove. The accelerometers may be used as actigraph devices to monitorrest/activity cycles of the patient. The activity score may be generatedbased on the rest/activity cycles of the patient. While operating in thelow complexity mode, the activity may be based on the outputs of theaccelerometers. While operating in the medium or high complexity mode,the activity may be based on the outputs of the accelerometers and theother sensors. This may include measuring and/or determining heart rate,heart rate variability and other parameters.

At 662, activity/RoM module 554 determines a RoM score based on theactivity score for a current day (or period of time). An activity scoreprovides a baseline surrogate score for RoM and may be used to determinethe RoM score. The table shown in FIG. 11 includes 10 example days ofPost-Op RoM percentages for ranges of RoM scores. Weighted daily averagescores are shown. Light activity refers to the range 0-2.5. Mediumactivity refers to the range 2.6-5.0. High activity refers to the range5.1-7.5. Vigorous activity refers to the range 7.6-10.

The activity score and/or the RoM score may be determined based onand/or as a function of information detected by the sensors includingECG ramp-rates, inter heart beat intervals, heart beats per minute, peakheart beats per minute, respiration ramp-rates, inter respiration beatintervals, peak inter respiration beat intervals, etc. As an example, asum of an activity score, an ECG score and a respiration score may bedetermined to provide a RoM score. The ECG score may be determined basedon and/or as a function of the ECG ramp-rates, inter heart beatintervals, heart beats per minute, and peak heart beats per minute. Therespiration score may be determined based on and/or as a function of therespiration ramp-rates, inter respiration beat intervals, and peak interrespiration beat intervals. At 664, the first cumulative module 558determines a cumulative RoM score. The cumulative RoM score may be a sumof the daily averaged RoM scores, as shown.

At 666, the QoS/pain module 556 may determine a number of sleepinterruptions during a sleep period and/or a QoS score. Theaccelerometers may be used as actigraph devices to monitor rest/activitycycles and determine an amount of sleep interruptions. Across-correlation between acceleration and velocity is an indicator ofspinal related pain. While operating in the low complexity mode, thenumber of sleep interruptions and/or the QoS score may be based on theoutputs of the accelerometers. While operating in the medium or highcomplexity mode, the number of sleep interruptions and/or a QoS scoremay be based on the outputs of the accelerometers and the other sensors.This may include measuring and/or determining heart rate, heart ratevariability and other parameters. The QoS score provides a baselinesurrogate score for pain. A low number of interruptions are shown by therange 0-2.5. A medium number of interruptions are shown by the range2.6-5. A high number of interruptions are shown by the range 5.1-7.5. Avery high number of interruptions are shown by the range 7.6-10. Each ofthe range values may refer to a number of interruptions per sleepperiod.

At 668, the QoS/pain module 556 determines a pain score (e.g., 1-10).FIG. 11 shows 10 days of Post-Op pain/QoS percentages. Weighted dailyaverage scores for QoS/pain are shown. A stress score and/or pain scoremay be determined based on and/or as a function of information detectedby the sensors including number of sleep interruptions, an ECG heartrate variability value, respiration ramp-rates, inter respiration beatintervals, and peak inter respiration beat intervals. The stress scoremay more of a neurological score, whereas the pain score may more of aphysiological score. The ECG heart rate variability value indicates howmuch a heart rate changes over a predetermined period of time. As anexample, the stress score may be determined based on a sum of the numberof sleep interruptions, the ECG heart rate variability value, and therespiration score.

At 670, the second cumulative module 560 determines a cumulative stressand/or pain score is determined based on the weighted daily averagesand/or stress scores determined at 618. This may include summing theweighted daily averages of pain/QoS scores, as shown.

At 672, the combined overall module 562 determines a Post-Op combinedscore based on the cumulative scores determined at 664, 670. An activityscore plus a QoS score provides a combined baseline surrogate score fora sum of a RoM score and a pain score. The Post-Op combined score may bea sum of the cumulative scores, as shown in FIG. 11. The Post-Opcombined score may also be based on instability and/or alignment scoresas determined at 656.

At 674, the control module 548 may store any and/or all of theabove-stated scores in one of the memories 304, 348, 354 and/or transmitthe scores to server 168. These scores may be stored with other scoresfor other patients for a particular procedure. The instability and/oralignment scores may be stored separate from and/or in a differentmemory than the activity, RoM, QoS, pain, and/or cumulative scores.

At 676, the control module 206 may determine whether scores for anotherday or predetermined period are to be generated. If more scores are tobe generated, task 652 may be performed; otherwise task 678 may beperformed. The Post-Op monitoring described above may be conducted for apredetermined period of time (e.g., 1 week) and may be monitored duringmost activities of daily life of the patient.

At 678, the control module determines an outcome score indicative ofwhether an outcome of the procedure is positive. A sum of a Post-Opactivity score and a corresponding Post-Op QoS score minus a sum of thePre-Op activity score and the corresponding Pre-Op QoS score provides anoutcome score that is indicative of whether the outcome of the procedureperformed is positive. A sum of a Post-Op RoM score and a correspondingPost-Op pain score minus a sum of the Pre-Op RoM score and thecorresponding Pre-Op pain score provides an outcome score that isindicative of whether the outcome of the procedure performed ispositive. The differences may be determined based on a day-by-day basisor for a more accurate outcome determination may be determined based ona difference between cumulative scores for a predetermined period oftime (e.g., 1 week). For example, a sum of the Post-Op cumulativeactivity score and the corresponding Post-Op cumulative QoS score minusa sum of the Pre-Op cumulative activity score and the correspondingPre-Op cumulative QoS score provides an outcome score that is indicativeof whether the outcome of the procedure performed is positive. A sum ofthe Post-Op cumulative RoM score and the corresponding Post-Opcumulative pain score minus a sum of the Pre-Op cumulative RoM score andthe corresponding Pre-Op cumulative pain score provides an outcome scorethat is indicative of whether the outcome of the procedure performed ispositive.

If one or more of the differences determined are positive, then theoutcome of the procedure is positive. Similarly, if one or more of thedifferences determined are negative, then the outcome of the procedureis negative.

At 680, the outcome scores, the differences, and/or whether the outcomeis positive or negative maybe stored in one of the memories 304, 348,354 for the procedure performed. This information may then be referencedfor future probability of positive outcome determinations. The methodmay end at 682.

The above-described tasks of FIGS. 9-10 are meant to be illustrativeexamples; the tasks may be performed sequentially, synchronously,simultaneously, continuously, during overlapping time periods or in adifferent order depending upon the application. Also, any of the tasksmay not be performed or skipped depending on the implementation and/orsequence of events.

As stated above, respiration rates may be monitored. In addition torespiration rates, blood oxygen levels may also be monitored to detectsleep apnea. This may be helpful in distinguishing sleep interruptiondue to pain from sleep apnea.

Also, to detect patient activity, movement of a patient may be detectedvia optical sensors and/or accelerometers. For example, optical analysisand optical diagnosis may be performed to detect movement and activityof a patient. Markers may be placed at key points on the anatomy of apatient. For example, markers may be placed on an iliac crest, spine,knees, shoulders, and/or other parts of a patient and movement of themarkers may be detected via optical sensors. Thus, the above-disclosedsystems may include optical sensors for monitoring, tracking anddetecting position and movement of markers and/or other objects. Signalsfrom the optical sensors may be received by one or more of theabove-disclosed modules. Accelerometers located on a patient may detectthe force of heal strikes as a patient walks or runs. The signals fromthe accelerometers may be used for gait analysis to augment the opticalmonitoring. This may also be performed by one or more of theabove-disclosed modules.

In addition, the disclosed sensing modules may include and/or beconnected to force sensing elements. The force sensing elements mayinclude strain gauges, piezo-electric or piezo-resistive elements,and/or other force sensing elements. The sensing elements may benon-intrusive elements and generate signals received by control modules(e.g., the control module 206 of FIG. 6) of the sensing modules. Theother sensing elements 417 may include the force sensing elements. Theforce sensing elements may be used to detect compression force (e.g.,hand compression force) and/or push or pull forces (e.g., arm push orpull force). The force sensing elements may be utilized, for example,during the medium complexity operating mode and/or the high complexityoperating mode in order to determine strength quantification valuesindicative of strength of a patient (e.g., upper body strength). Loss ofupper body strength is an indicator of spine health. In one embodiment,a strength determination is not performed during the low complexityoperating mode, a hand compression force (e.g., determined by squeezinga rubber ball having a force-gauge or force sensing element) isdetermined during the medium complexity operating mode, and a handcompression force and an arm push and/or pull force are determinedduring the high complexity operating mode. The force determinations andstrength values may be used in the methods disclosed herein to the rangeof motion values and/or quality of sleep values.

The above disclosed examples provide systems for providing clinicalevidence for positive procedure outcomes. The systems determine pre andpost scores for determining times for maximizing probability of positiveoutcomes and for determining whether a procedure has provided a positiveoutcome. The probabilities are determined based on stored historicaldata that continues to grow with each additionally performed procedure.

The wireless communications described in the present disclosure can beconducted in full or partial compliance with IEEE standard 802.11-2012,IEEE standard 802.16-2009, IEEE standard 802.20-2008, and/or BluetoothCore Specification v4.0. In various implementations, Bluetooth CoreSpecification v4.0 may be modified by one or more of Bluetooth CoreSpecification Addendums 2, 3, or 4. In various implementations, IEEE802.11-2012 may be supplemented by draft IEEE standard 802.11ac, draftIEEE standard 802.11ad, and/or draft IEEE standard 802.11ah.

The foregoing description is merely illustrative in nature and is in noway intended to limit the disclosure, its application, or uses. Thebroad teachings of the disclosure can be implemented in a variety offorms. Therefore, while this disclosure includes particular examples,the true scope of the disclosure should not be so limited since othermodifications will become apparent upon a study of the drawings, thespecification, and the following claims. It should be understood thatone or more steps within a method may be executed in different order (orconcurrently) without altering the principles of the present disclosure.Further, although each of the embodiments is described above as havingcertain features, any one or more of those features described withrespect to any embodiment of the disclosure can be implemented in and/orcombined with features of any of the other embodiments, even if thatcombination is not explicitly described. In other words, the describedembodiments are not mutually exclusive, and permutations of one or moreembodiments with one another remain within the scope of this disclosure.

Spatial and functional relationships between elements (for example,between modules, circuit elements, semiconductor layers, etc.) aredescribed using various terms, including “connected,” “engaged,”“coupled,” “adjacent,” “next to,” “on top of,” “above,” “below,” and“disposed.” Unless explicitly described as being “direct,” when arelationship between first and second elements is described in the abovedisclosure, that relationship can be a direct relationship where noother intervening elements are present between the first and secondelements, but can also be an indirect relationship where one or moreintervening elements are present (either spatially or functionally)between the first and second elements. As used herein, the phrase atleast one of A, B, and C should be construed to mean a logical (A OR BOR C), using a non-exclusive logical OR, and should not be construed tomean “at least one of A, at least one of B, and at least one of C.”

In this application, including the definitions below, the term “module”or the term “controller” may be replaced with the term “circuit.” Theterm “module” may refer to, be part of, or include: an ApplicationSpecific Integrated Circuit (ASIC); a digital, analog, or mixedanalog/digital discrete circuit; a digital, analog, or mixedanalog/digital integrated circuit; a combinational logic circuit; afield programmable gate array (FPGA); a processor circuit (shared,dedicated, or group) that executes code; a memory circuit (shared,dedicated, or group) that stores code executed by the processor circuit;other suitable hardware components that provide the describedfunctionality; or a combination of some or all of the above, such as ina system-on-chip.

The module may include one or more interface circuits. In some examples,the interface circuits may include wired or wireless interfaces that areconnected to a local area network (LAN), the Internet, a wide areanetwork (WAN), or combinations thereof. The functionality of any givenmodule of the present disclosure may be distributed among multiplemodules that are connected via interface circuits. For example, multiplemodules may allow load balancing. In a further example, a server (alsoknown as remote, or cloud) module may accomplish some functionality onbehalf of a client module.

The term code, as used above, may include software, firmware, and/ormicrocode, and may refer to programs, routines, functions, classes, datastructures, and/or objects. The term shared processor circuitencompasses a single processor circuit that executes some or all codefrom multiple modules. The term group processor circuit encompasses aprocessor circuit that, in combination with additional processorcircuits, executes some or all code from one or more modules. Referencesto multiple processor circuits encompass multiple processor circuits ondiscrete dies, multiple processor circuits on a single die, multiplecores of a single processor circuit, multiple threads of a singleprocessor circuit, or a combination of the above. The term shared memorycircuit encompasses a single memory circuit that stores some or all codefrom multiple modules. The term group memory circuit encompasses amemory circuit that, in combination with additional memories, storessome or all code from one or more modules.

The term memory circuit is a subset of the term computer-readablemedium. The term computer-readable medium, as used herein, does notencompass transitory electrical or electromagnetic signals propagatingthrough a medium (such as on a carrier wave); the term computer-readablemedium may therefore be considered tangible and non-transitory.Non-limiting examples of a non-transitory, tangible computer-readablemedium are nonvolatile memory circuits (such as a flash memory circuit,an erasable programmable read-only memory circuit, or a mask read-onlymemory circuit), volatile memory circuits (such as a static randomaccess memory circuit or a dynamic random access memory circuit),magnetic storage media (such as an analog or digital magnetic tape or ahard disk drive), and optical storage media (such as a CD, a DVD, or aBlu-ray Disc).

The apparatuses and methods described in this application may bepartially or fully implemented by a special purpose computer created byconfiguring a general purpose computer to execute one or more particularfunctions embodied in computer programs. The apparatuses and methods maybe implemented in, for example, a handheld instrument, a tablet, a smartphone, a cellular phone, and/or other computing device. The functionalblocks, flowchart components, and other elements described above serveas software specifications, which can be translated into the computerprograms by the routine work of a skilled technician or programmer.

The computer programs include processor-executable instructions that arestored on at least one non-transitory, tangible computer-readablemedium. The computer programs may also include or rely on stored data.The computer programs may encompass a basic input/output system (BIOS)that interacts with hardware of the special purpose computer, devicedrivers that interact with particular devices of the special purposecomputer, one or more operating systems, user applications, backgroundservices, background applications, etc.

The computer programs may include: (i) descriptive text to be parsed,such as HTML (hypertext markup language) or XML (extensible markuplanguage), (ii) assembly code, (iii) object code generated from sourcecode by a compiler, (iv) source code for execution by an interpreter,(v) source code for compilation and execution by a just-in-timecompiler, etc. As examples only, source code may be written using syntaxfrom languages including C, C++, C#, Objective C, Haskell, Go, SQL, R,Lisp, Java®, Fortran, Perl, Pascal, Curl, OCaml, Javascript®, HTML5,Ada, ASP (active server pages), PHP, Scala, Eiffel, Smalltalk, Erlang,Ruby, Flash®, Visual Basic®, Lua, and Python®.

None of the elements recited in the claims are intended to be ameans-plus-function element within the meaning of 35 U.S.C. § 112(f)unless an element is expressly recited using the phrase “means for,” orin the case of a method claim using the phrases “operation for” or “stepfor.”

What is claimed is:
 1. A spinal kinematics system for measuring objective parameters used to determine whether an outcome of a procedure is positive based on vertebral motion analysis of a patient, the system comprising: at least one imaging sensor configured to image and measure vertebral displacement; at least one motion sensor configured detect motion of a patient; and a monitoring device that comprises: a wireless interface adapter in communication with and which receives information from the at least one imaging sensor and the at least one motion sensor, and a control circuit having a processor and a memory and is configured to process information received from the at least one imaging sensor and the at least one motion sensor; wherein the control circuit is further configured to determine, post-operation for the patient: an activity score, based on the vertebral displacement measured by the at least one imaging sensor and the motion detected by the at least one motion sensor, that measures a rest-activity cycle of the patient for a predetermined activity period; a cumulative activity score by summing weighted daily averages of a plurality of activity scores across a plurality of predetermined activity periods; a combined score calculated using the cumulative activity score; and whether the outcome of the procedure is positive by comparing the combined score to a second combined score, the second combined score being determined for the patient prior to performing the procedure.
 2. The system according to claim 1, wherein the at least one motion sensor is a three-axis motion sensor or nine-axis motion sensor.
 3. The system according to claim 1, wherein the activity score is further determined by measuring a size of a radius of an arc formed by a curvature of a spine of the patient.
 4. The system according to claim 1, wherein the activity score is determined based on a scale of 0 to
 10. 5. The system according to claim 1, further comprising: at least one parametric sensor configured to measure one or more first parameters associated with the patient, wherein the control circuit is further configured to determine a quality of sleep score, based on information generated by the at least one parametric sensor, the at least one parametric sensor being further configured to measure a number of sleep interruptions during a predetermined sleep period.
 6. The system according to claim 5, wherein one or more first parameters are selected from a list consisting of voltages, frequencies, current levels, durations, amplitudes, temperatures, impedances, resistances, and wavelengths.
 7. The system according to claim 5, wherein the activity score is further based on one or more second parameters generated by the monitoring device using one or more of the first parameters generated by the at least one parametric sensor.
 8. The system according to claim 7, wherein the one or more second parameters are selected from a list consisting of durations, oxygen levels, temperatures, impedances, pH levels, accelerations, amplitudes, heart rates, blood pressures, electro-cardiogram (ECG) parameters, respiratory parameters, body activity values, heart sounds, blood gas pH, red blood cell counts, white blood cell counts, and electro-encephologram (EEG) parameters.
 9. The system according to claim 5, wherein the control circuit further comprises a posture circuit configured to analyze information generated by the at least one imaging sensor and the at least one motion sensor, wherein the control circuit is further configured to determine: a posture state of the patient, using the posture circuit, based on information generated by the at least one imaging sensor and the at least one motion sensor; a motion score based on information generated by the at least one motion sensor; and a pain score based on the number of sleep interruptions, wherein the activity score of the patient is further determined based on the posture state of the patient and the activity score; and wherein the quality of sleep score of the patient is further determined based on the posture state of the patient and the pain score.
 10. The system according to claim 9, wherein the control circuit further comprises a prone circuit configured to analyze information generated by the at least one imaging sensor and the at least one motion sensor, and wherein the control circuit is further configured to determine: whether the patient is in a prone state using the prone circuit; the quality of sleep score if the patient is in the prone state; and the activity score if the patient is not in the prone state.
 11. A method for measuring, post-operation for a patient, objective parameters used to determine whether an outcome of a procedure is positive based on vertebral motion analysis of the patient for use in a spinal kinematics system, the method comprising: measuring, using at least one imaging sensor, vertebral displacement; detecting, using at least one motion sensor, motion of the patient; calculating, based on the measured vertebral displacement and the detected motion, an activity score that measures a rest-activity cycle of the patient for a predetermined activity period; determining a cumulative activity score based on weighted daily averages of a plurality of activity scores across a plurality of predetermined activity periods; determining a combined score calculated using at least the cumulative activity score; and determining whether the outcome of the procedure is positive by comparing the combined score to a second combined score, the second combined score being determined for the patient prior to performing the procedure.
 12. The method according to claim 11, wherein the at least one motion sensor is a three-axis motion sensor or nine-axis motion sensor.
 13. The method according to claim 11, further comprising measuring a spinal curvature of the patient based on a size of a radius of an arc formed by a curvature of a spine, wherein the activity score is determined using the spinal curvature.
 14. The method according to claim 11, wherein the activity score is determined based on a scale of 0 to
 10. 15. The method according to claim 11, further comprising: measuring, using at least one parametric sensor, one or more first parameters associated with the patient; calculating, based on the detected motion and one or more of the first parameters, a quality of sleep score that measures a number of sleep interruptions during a predetermined sleep period; determining a cumulative quality of sleep score based on weighted daily averages of a plurality of quality of sleep scores across a plurality of predetermined sleep periods; and determining the combined baseline score by calculating the sum of the cumulative activity score and the cumulative quality of sleep score.
 16. The method according to claim 15, wherein the first parameters are selected from a list consisting of voltages, frequencies, current levels, durations, amplitudes, temperatures, impedances, resistances, and wavelengths.
 17. The method according to claim 15, further comprising generating, based on the one or more first parameters, one or more second parameters, wherein the activity score is further based on the one or more second parameters.
 18. The method according to claim 17, wherein the one or more second parameters are selected from a list consisting of durations, oxygen levels, temperatures, impedances, pH levels, accelerations, amplitudes, heart rates, blood pressures, electro-cardiogram (ECG) parameters, respiratory parameters, body activity values, heart sounds, blood gas pH, red blood cell counts, white blood cell counts, and electro-encephologram (EEG) parameters.
 19. The method of claim 15, further comprising: determining, using a posture circuit, a posture state of the patient based on information generated by the at least one imaging sensor and the at least one motion sensor; determining a motion score based the motion detected by the at least one motion sensor; determining a pain score based on the number of sleep interruptions; determining the activity score based on the posture state of the patient and the activity score; and determining the quality of sleep score of the patient based on the posture state of the patient and the pain score.
 20. The method according to claim 19, further comprising: determining, using a prone circuit, whether the patient is in a prone state based on information generated by the at least one imaging sensor and the at least one motion sensor; determining the quality of sleep score if the patient is in the prone state; and determining the activity score if the patient is not in the prone state.
 21. The method according to claim 11, further comprising predicting an outcome of a second procedure based on the determined outcome and the combined score. 